Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01263769
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2010-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jakaram@mdanderson.org', 'phone': '(713) 745-0374', 'title': 'Dr. Jose Karam, MD, Associate Professor, Urology', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years', 'description': 'No participant deaths reported throughout study.', 'eventGroups': [{'id': 'EG000', 'title': 'Axitinib', 'description': '5 mg by mouth twice each day for 12 weeks.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 19, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 15}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hand-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'AST/ALT increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Scrotal skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': '5 mg by mouth twice each day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '42.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Objective response rate is defined as Complete Response (CR)+ Partial Response (PR) and evaluated when CT abdomen is done after 12 weeks of treatment. Per Response Evaluation Criteria in Solid Tumors Criteria ( RECIST v1.0) Complete Response (CR) is complete disappearance of renal mass; and, Partial Response (PR) is \\>= 30% decrease in the largest diameter (LD) of the renal mass taking as reference the baseline largest diameter.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrence Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants received 12 weeks of neoadjuvant followed by radical nephrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '103.1', 'comment': 'Not estimable for the upper found of the 95% Confidence Interval due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After completion of treatment, patients followed w/evaluations every 4 months for 1st year, then every 6 months for next 2 years, yearly until disease progression identified or start of new treatment & yearly survival thereafter until study completion', 'description': 'We will evaluate recurrence-free survival by plotting Kaplan-Meier curves and estimating median recurrence-free survival. RFS is the time from reatment start until death, recurrence or progressive disease, whichever comes first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Anyone who received study treatment'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants received 12 weeks of neoadjuvant treatment followed by radical nephrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not reached for meeting OS and not estimable for the 95% Confidence Interval due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the date of death from any cause, or date of last follow-up, whichever came first, assessed up to 5 years', 'description': 'We will evaluate overall survival by plotting Kaplan-Meier curves and estimating median overall survival. OS is the time from treatment start until death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Anyone who received study treatment.'}, {'type': 'SECONDARY', 'title': 'Postoperative Complications-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants received 12 weeks of neoadjuvant treatment followed by radical nephrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From surgery until 30 days after surgery', 'description': 'We used Clavien-Dindo score to record postoperative complications of any grade (Grade 1 thru 5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anyone who received study treatment and completed the 30-day post-op FU visit'}, {'type': 'SECONDARY', 'title': 'Surgery-related Complications - High Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib', 'description': 'Participants received 12 weeks of neoadjuvant treatment followed by radical nephrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From surgery until 30 days after surgery', 'description': 'We used Clavien-Dindo score to record postoperative complications of high grade (Grade 3-5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anyone who received study treatment and completed the 30-day post-op FU visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axitinib', 'description': '5 mg by mouth twice each day for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Non-Compliant with treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '39 participants consented, but 14 not treated (11 not meeting criteria and 3 declined). Only 25 underwent treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Axitinib', 'description': '5 mg by mouth twice each day for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-23', 'size': 593871, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-30T12:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2010-12-17', 'resultsFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-01', 'studyFirstPostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '12 weeks', 'description': 'Objective response rate is defined as Complete Response (CR)+ Partial Response (PR) and evaluated when CT abdomen is done after 12 weeks of treatment. Per Response Evaluation Criteria in Solid Tumors Criteria ( RECIST v1.0) Complete Response (CR) is complete disappearance of renal mass; and, Partial Response (PR) is \\>= 30% decrease in the largest diameter (LD) of the renal mass taking as reference the baseline largest diameter.'}], 'secondaryOutcomes': [{'measure': 'Recurrence Free Survival', 'timeFrame': 'After completion of treatment, patients followed w/evaluations every 4 months for 1st year, then every 6 months for next 2 years, yearly until disease progression identified or start of new treatment & yearly survival thereafter until study completion', 'description': 'We will evaluate recurrence-free survival by plotting Kaplan-Meier curves and estimating median recurrence-free survival. RFS is the time from reatment start until death, recurrence or progressive disease, whichever comes first.'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of randomization until the date of death from any cause, or date of last follow-up, whichever came first, assessed up to 5 years', 'description': 'We will evaluate overall survival by plotting Kaplan-Meier curves and estimating median overall survival. OS is the time from treatment start until death.'}, {'measure': 'Postoperative Complications-Any Grade', 'timeFrame': 'From surgery until 30 days after surgery', 'description': 'We used Clavien-Dindo score to record postoperative complications of any grade (Grade 1 thru 5)'}, {'measure': 'Surgery-related Complications - High Grade', 'timeFrame': 'From surgery until 30 days after surgery', 'description': 'We used Clavien-Dindo score to record postoperative complications of high grade (Grade 3-5)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally advanced clear cell renal cell carcinoma', 'AG-013736', 'Axitinib', 'Radical nephrectomy'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'references': [{'pmid': '24560330', 'type': 'DERIVED', 'citation': 'Karam JA, Devine CE, Urbauer DL, Lozano M, Maity T, Ahrar K, Tamboli P, Tannir NM, Wood CG. Phase 2 trial of neoadjuvant axitinib in patients with locally advanced nonmetastatic clear cell renal cell carcinoma. Eur Urol. 2014 Nov;66(5):874-80. doi: 10.1016/j.eururo.2014.01.035. Epub 2014 Feb 7.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to learn if axitinib can help to control kidney cancer. The safety of this drug will also be studied.', 'detailedDescription': 'The Study Drug:\n\nAxitinib is designed to decrease blood supply to the tumor, which may slow tumor growth.\n\nStudy Drug Administration:\n\nIf you are found to be eligible to take part in this study, you will take axitinib by mouth 2 times a day every day for 12 weeks. The dose may be changed based on any side effects you may have. You should take the drug about 12 hours apart. You should take the pills at about the same time each day. If you vomit anytime after taking a dose, you must not "make it up" with an extra dose, but instead take the next dose as previously scheduled. Any missed dose may be taken late up to 3 hours before the next scheduled dose, otherwise, it should be skipped.\n\nA blood pressure monitor will be given to each participant for home use. You will be given instructions and shown how to monitor your blood pressure.\n\nYou will be provided with a calendar to record the date and time of each dose, and your blood pressure reading before taking the drug. Missed doses should also be recorded. You must also bring the study drug bottle to each study visit so the research nurse can count any remaining pills.\n\nA drug list will be given to you to record drugs taken within 4 weeks before you enrolled on the study and while on study. A new list will be provided during each clinic visit. You should not start a new prescription or over-the-counter drug before talking with the study doctor, except in the case of a medical emergency.\n\nStudy Visits:\n\nAt Week 1:\n\n* You will be asked about any drugs you may be taking.\n* Your performance status will be recorded.\n* You will complete the questionnaire about kidney cancer care. This questionnaire will take about 5 minutes to complete.\n* Women who are able to become pregnant will have a blood (about 1 teaspoon) or urine pregnancy test.\n\nAt Week 3:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Your performance status will be recorded.\n* You will have an ECG.\n* Blood (about 2 tablespoons) will be drawn for routine testing to check your thyroid function.\n* Urine (about 2 tablespoons) will be collected for routine testing.\n* You will complete the questionnaire about kidney cancer care.\n\nAt Weeks 5 and 9, you will be called and asked if you have had any side effects. This call should take about 10 minutes.\n\nAt Weeks 7 and 12:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Your performance status will be recorded.\n* Blood (about 2 tablespoons) will be drawn for routine testing and to check your thyroid function.\n* Urine (about 2 tablespoons) will be collected for routine testing.\n* You will complete the questionnaire about kidney cancer care.\n* You will have a CT scan of chest and abdomen to check the status of the disease.\n* At Week 12 only, you will have an ECG.\n\nAt Week 13, you will have surgery to remove the kidney tumor. You will receive a separate consent form for this surgery.\n\nAt Week 19:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Your performance status will be recorded.\n* Blood (about 2 tablespoons) will be drawn for routine testing and to check your thyroid function.\n* You will complete the questionnaire about kidney cancer care.\n* You will have a CT scan of chest and abdomen to check the status of the disease.\n* If you have been treated for high blood pressure while taking the drug, your blood pressure will be monitored and your blood pressure medication will be reduced. Once your blood pressure reaches a certain level, this will be managed by your primary care doctor.\n\nAfter Week 19, every 4 months (+/- 2 weeks) for the first 1 year, every 6 months (+/- 2 weeks) for the third and fourth year, then every year (+/- 1 month) for a total of 5 years post surgery:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Your performance status will be recorded.\n* You will have a CT scan of the chest and abdomen to check the status of the disease.\n* Blood (about 2 tablespoons) will be drawn for routine testing and to check your thyroid function.\n* You will complete the questionnaire about kidney cancer care (only during the first 2 years).\n\nLength of Study:\n\nYou will take axitinib for up to 12 weeks. You will stop taking axitinib earlier than expected if the disease gets worse or if you have severe side effects. In both cases, you will move on to surgery after axitinib has been stopped.\n\nAfter surgery, you will be contacted by the study staff every 4 months (+/- 2 weeks) for 1 year, every 6 months (+/- 2 weeks) for the next 2 years and every 12 months (+/- 1 month) for 2 more years (for a total of 5 years after surgery).\n\nThis is an investigational study. Axitinib is FDA approved and commercially available to treat advanced kidney cancer in adults when 1 previous drug treatment for this disease has not worked. In this study, it is being used for research purposes.\n\nUp to 40 patients will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Locally advanced renal cell carcinoma without evidence of metastatic disease with absence of adjacent organ invasion or retroperitoneal adenopathy (cT2-T3b, N0, M0). Patients with retroperitoneal lymph nodes \\</= 2cm in size each are considered N0.\n2. Predominant clear cell histology on pre-treatment biopsy of the primary tumor.\n3. Patient should be candidate for curative radical nephrectomy.\n4. ECOG Performance Status 0-1.\n5. Patient must provide signed informed consent.\n6. Male or female, age \\>/= 18 years.\n7. Adequate renal function: serum creatinine level \\</=1.5 x ULN or calculated creatinine clearance (as estimated by GFR using the MDRD formula) is \\>/= 60 ml/min.\n8. Adequate hepatic function: alkaline phosphatase \\</= 1.5 x ULN; total bilirubin, AST, and ALT \\</= 1.5 x ULN; INR \\<1.3 (or \\<3 if on anticoagulant therapy).\n9. Adequate bone marrow function: ANC \\>/= 1.5 x 10/ 9L; Platelets \\>/= 100 x 109/L; Hb \\>9 g/dL\n10. Urinary protein \\<100 on urinalysis (equivalent to \\<2+ by urine dipstick). If urinalysis protein \\>/=100 (equivalent to dipstick is \\>/=2+) then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \\<2 g per 24 hours\n11. No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the 5 years prior to current study enrollment.\n12. Women of childbearing potential (defined as a female subject who is not surgically sterilized, not at least 1 year postmenopausal) must have negative urine or serum pregnancy test within 4 weeks of enrollment and again on the day of starting therapy and she and/or her partner must utilize birth control while on therapy.\n13. Male (defined as a male subject who has not been surgically sterilized) or female patients of child-producing potential must agree to use adequate contraception (e.g. IUD, condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: as of date of study enrollment and for at least 1 month after last dose of axitinib. Subjects who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.\n\nExclusion Criteria:\n\n1. Evidence of metastatic disease, adjacent organ invasion, retroperitoneal adenopathy on pre-treatment imaging. In addition, patients with inferior vena cava thrombi extending to the atrium or with evidence of Budd-Chiari Syndrome (hepatic dysfunction) will not be eligible for the protocol.\n2. Patients who undergo embolization of their primary tumor.\n3. Previous treatment for their primary renal tumor, including prior chemotherapy, immunotherapy, targeted therapy, radiation therapy, cryotherapy, radiofrequency ablation or embolization.\n4. Active malignancies other than renal cell carcinoma and/or history of other malignancy within the last 5 years, except for adequately treated cone-biopsied in situ carcinoma of the cervix or basal or squamous cell carcinoma of the skin\n5. Uncontrolled hypertension (BP\\>140/90 on medications), as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be \\</=140 mm Hg, and the baseline diastolic blood pressure readings must be \\</=90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.\n6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, nefazodone, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).\n7. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).\n8. Active gastrointestinal bleeding.\n9. Malabsorption syndromes such as celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndrome.\n10. Known HIV or Hepatitis C status.\n11. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.\n12. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.\n13. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.\n14. Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism\n15. Withdrawal of consent.\n16. Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen."}, 'identificationModule': {'nctId': 'NCT01263769', 'briefTitle': 'Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Phase II Clinical Trial Examining the Impact Of Neoadjuvant Axitinib On Primary Tumor Response In Patients With Locally Advanced Clear Cell Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '2010-0072'}, 'secondaryIdInfos': [{'id': 'NCI-2011-00279', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Axitinib', 'description': 'Axitinib Starting dose: 5 mg by mouth twice each day for 12 weeks.', 'interventionNames': ['Drug: Axitinib']}], 'interventions': [{'name': 'Axitinib', 'type': 'DRUG', 'otherNames': ['AG-013736'], 'description': 'Starting dose: 5 mg by mouth twice each day for 12 weeks.', 'armGroupLabels': ['Axitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jose Karam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}