Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00058318
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2003-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2003-04-07', 'studyFirstSubmitQcDate': '2003-04-08', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'timeFrame': 'every 8 weeks until progression'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years'}, {'measure': 'Time to treatment failure', 'timeFrame': 'every 8 weeks until progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV renal cell cancer', 'stage III renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'references': [{'pmid': '19487915', 'type': 'RESULT', 'citation': 'Van Veldhuizen PJ, Hussey M, Lara PN Jr, Mack PC, Gandour-Edwards R, Clark JI, Lange MK, Crawford DE. A phase ii study of gemcitabine and capecitabine in patients with advanced renal cell cancer: Southwest Oncology Group Study S0312. Am J Clin Oncol. 2009 Oct;32(5):453-9. doi: 10.1097/COC.0b013e3181925176.'}, {'type': 'RESULT', 'citation': 'van Veldhuizen PJ, Hussey M, Lara PN, et al.: A phase II study of IV gemcitabine (G) and oral capecitabine (C) in patients (pts) with advanced renal cell cancer (RCC): results of Southwest Oncology Group study 0312. [Abstract] J Clin Oncol 25 (Suppl 18): A-15562, 654s, 2007.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced renal cell cancer (kidney cancer).', 'detailedDescription': 'OBJECTIVES:\n\n* Determine response (confirmed and unconfirmed complete and partial) of patients with advanced renal cell cancer treated with gemcitabine and capecitabine.\n* Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this regimen.\n* Determine the qualitative and quantitative toxic effects of this regimen in these patients.\n* Correlate, preliminarily, tumor response with the intratumoral content of the enzymes involved in the activation and degradation of these drugs in these patients.\n\nOUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 3.8-4.2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed renal cell carcinoma\n\n * Metastatic (M1) disease OR\n * M0 provided the primary tumor is unresectable\n* Measurable disease\n\n * At least 1 unidimensionally measurable lesion\n * Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease\n * Soft tissue disease within a prior radiation field is measurable provided it has progressed since therapy and there is also measurable disease outside of the irradiated field\n* No prior or concurrent brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN\n\nRenal\n\n* Creatinine clearance at least 50 mL/min\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other concurrent uncontrolled illness that would preclude study participation\n* No psychiatric illness or social situation that would preclude study compliance\n* No uncontrolled diabetes mellitus\n* No ongoing or active infection\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No more than 2 prior immunotherapy regimens comprising interferon (IFN) and/or interleukin-2 (IL-2)\n* At least 28 days since prior IFN or IL-2 and recovered\n\nChemotherapy\n\n* No prior chemotherapy for renal cell cancer\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* No prior radiotherapy to 25% or more of the bone marrow\n* At least 21 days since prior radiotherapy and recovered\n\nSurgery\n\n* At least 28 days since prior surgery and recovered\n* Prior resection of the primary tumor allowed (in patients with metastatic disease)\n\nOther\n\n* At least 4 weeks since prior sorivudine or brivudine\n* No concurrent sorivudine or chemically related analogues (e.g., brivudine)'}, 'identificationModule': {'nctId': 'NCT00058318', 'briefTitle': 'S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer', 'orgStudyIdInfo': {'id': 'CDR0000288820'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'S0312', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Gemcitabine + Capecitabine', 'interventionNames': ['Drug: capecitabine', 'Drug: gemcitabine hydrochloride']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': 'Capecitabine will be given 625 mg/m\\^2 (1250 mg/m\\^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progression', 'armGroupLabels': ['Treatment']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': 'Gemcitabine will be given 900 mg/m\\^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter J. VanVeldhuizen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kansas City Veteran Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}