Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-31 @ 5:29 AM
Study NCT ID:
NCT00054457
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2003-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-09', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of successes', 'timeFrame': 'Up to 3.5 years'}], 'secondaryOutcomes': [{'measure': 'Survival time', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Time to disease progression', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Duration of response', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Time to treatment failure', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires', 'timeFrame': 'Up to 3.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the stomach', 'adenocarcinoma of the esophagus', 'stage IV gastric cancer', 'recurrent gastric cancer', 'stage IV esophageal cancer', 'recurrent esophageal cancer'], 'conditions': ['Esophageal Cancer', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '20126980', 'type': 'BACKGROUND', 'citation': 'Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.'}, {'pmid': '17265786', 'type': 'RESULT', 'citation': 'Jatoi A, Nguyen PL, Foster N, Sun D, Stella PJ, Campbell M, Tschetter LK, Dakhil SR, Mailliard JA, Nikcevich DA. Interleukin-1 genetic polymorphisms and their relationship to the cancer anorexia/weight loss syndrome in metastatic gastric and gastroesophageal junction adenocarcinoma. J Support Oncol. 2007 Jan;5(1):41-6.'}, {'pmid': '16497828', 'type': 'RESULT', 'citation': 'Giordano KF, Jatoi A, Stella PJ, Foster N, Tschetter LK, Alberts SR, Dakhil SR, Mailliard JA, Flynn PJ, Nikcevich DA; North Central Cancer Treatment Group. Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Apr;17(4):652-6. doi: 10.1093/annonc/mdl005. Epub 2006 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.\n* Determine the time to progression in patients treated with this regimen.\n* Determine the overall survival in patients treated with this regimen.\n* Determine the toxic effects of this regimen in these patients.\n* Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis.\n* Assess the quality of life and swallowing uniscale during chemotherapy in these patients.\n\nOUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.\n\nPatients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n* Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy)\n\n * At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)\n * No other more conventional forms of therapy available with a reasonable chance of cure or significant palliation\n* Measurable disease\\*\n\n * The following are not considered measurable disease:\n\n * Bone lesions\n * Leptomeningeal disease\n * Ascites\n * Pleural/pericardial effusion\n * Lymphangitis cutis/pulmonis\n * Abdominal masses that are not confirmed and followed by imaging\n * Cystic lesions NOTE: \\*Patients having only lesions measuring ≥ 1 cm to \\< 2 cm must use spiral CT scan for all tumor assessments.\n* No untreated or treated but symptomatic CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* AST no greater than 2.5 times ULN if alkaline phosphatase is less than ULN OR\n* Alkaline phosphatase no greater than 4 times ULN if AST less than ULN\n\nRenal\n\n* Creatinine normal\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular\n\n* No New York Heart Association class III or IV heart disease\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Ability to swallow capecitabine\n* No prior anaphylactic reaction to any taxane\n* No prior severe reaction to fluoropyrimidine\n* No prior poor tolerance to capecitabine\n* No known sensitivity or poor tolerance to fluorouracil\n* No known dihydropyrimidine dehydrogenase deficiency\n* No uncontrolled infection\n* No uncontrolled seizure disorder\n* No chronic debilitating disease\n* No peripheral neuropathy of any etiology greater than grade 1\n* No diabetes mellitus\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma or adequately treated noninvasive carcinoma\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior immunotherapy or biologic therapy for recurrent or metastatic disease\n* No concurrent biologic therapy\n\nChemotherapy\n\n* No prior chemotherapy for recurrent or metastatic disease except for the following:\n\n * Adjuvant chemotherapy after complete resection of the original tumor\n * Neoadjuvant chemotherapy followed by surgical resection of the original tumor\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy except for the following:\n\n * Adjuvant radiotherapy after complete resection of the original tumor\n * Neoadjuvant radiotherapy followed by surgical resection of the original tumor\n* No prior radiotherapy to 25% or more of the bone marrow\n* More than 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* No prior organ allograft\n\nOther\n\n* No concurrent brivudine or sorivudine'}, 'identificationModule': {'nctId': 'NCT00054457', 'briefTitle': 'Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction', 'orgStudyIdInfo': {'id': 'NCCTG-N0242'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02517', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'CDR0000270681', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'docetaxel + capecitabine', 'description': 'Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.\n\nPatients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.', 'interventionNames': ['Drug: capecitabine', 'Drug: docetaxel']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + capecitabine']}, {'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66720', 'city': 'Chanute', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Chanute', 'geoPoint': {'lat': 37.67921, 'lon': -95.4572}}, {'zip': '67801', 'city': 'Dodge City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Dodge City', 'geoPoint': {'lat': 37.7528, 'lon': -100.01708}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - El Dorado', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '67068', 'city': 'Kingman', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Kingman', 'geoPoint': {'lat': 37.64585, 'lon': -98.11367}}, {'zip': '67901', 'city': 'Liberal', 'state': 'Kansas', 'country': 'United States', 'facility': 'Southwest Medical Center', 'geoPoint': {'lat': 37.04308, 'lon': -100.921}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Newton', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67357', 'city': 'Parsons', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Parsons', 'geoPoint': {'lat': 37.34034, 'lon': -95.26108}}, {'zip': '67124', 'city': 'Pratt', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Pratt', 'geoPoint': {'lat': 37.64391, 'lon': -98.73759}}, {'zip': '67042', 'city': 'Salina', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Salina', 'geoPoint': {'lat': 38.84028, 'lon': -97.61142}}, {'zip': '67152', 'city': 'Wellington', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Wellington', 'geoPoint': {'lat': 37.2653, 'lon': -97.37171}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Associates in Womens Health, PA - North Review', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Medical Arts Tower', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Cancer Center at Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67156', 'city': 'Winfield', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Winfield', 'geoPoint': {'lat': 37.23975, 'lon': -96.99559}}, {'zip': '55337', 'city': 'Burnsville', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Ridges Hospital', 'geoPoint': {'lat': 44.76774, 'lon': -93.27772}}, {'zip': '55433', 'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy and Unity Cancer Center at Mercy Hospital', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy and Unity Cancer Center at Unity Hospital', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '55109', 'city': 'Maplewood', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology, PA - Maplewood', 'geoPoint': {'lat': 44.95302, 'lon': -92.99522}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Virginia Piper Cancer Institute at Abbott - Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55422-2900', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Metro-Minnesota', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet Cancer Center', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '55387', 'city': 'Waconia', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ridgeview Medical Center', 'geoPoint': {'lat': 44.8508, 'lon': -93.78691}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology, PA - Woodbury', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}], 'overallOfficials': [{'name': 'Aminah Jatoi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}