Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 8:14 AM
Study NCT ID:
NCT00274859
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2006-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2008-07-23', 'studyFirstSubmitDate': '2006-01-10', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate'}], 'secondaryOutcomes': [{'measure': 'Clinical benefit'}, {'measure': 'Tolerability'}, {'measure': 'Progression-free'}, {'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.\n\nPURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.\n\nSecondary\n\n* Determine the clinical benefit and tolerability of this regimen in these patients.\n* Determine the progression-free and overall survival of patients treated with this regimen.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically.\n\nPROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed cancer\n\n * Metastatic disease\n* Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm\n* Not a candidate for anthracycline or taxane chemotherapy\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%\n* Life expectancy \\> 12 weeks\n* Neutrophil count \\> 1,000/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n* Alkaline phosphatase \\< 5 times upper limit of normal (ULN)\n* Bilirubin \\< 1.5 times ULN\n* Creatinine \\< 1.5 times ULN OR creatinine clearance \\> 30 mL/min\n* SGOT and SGPT \\< 3 times ULN (5 times ULN if liver metastases present)\n* No pre-existing neuropathy\n* Not pregnant or nursing\n* No uncontrolled hypercalcemia\n* No familial, social, geographical, or psychological condition that would preclude study treatment\n* No other malignancy that is not considered cured\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy for metastatic disease, including anthracyclines or taxanes\n* Prior hormonal therapy allowed'}, 'identificationModule': {'nctId': 'NCT00274859', 'briefTitle': 'Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes', 'orgStudyIdInfo': {'id': 'CDR0000454320'}, 'secondaryIdInfos': [{'id': 'GERCOR-SEGEMOX-S04-1'}, {'id': 'LILLY-GERCOR-SEGEMOX-S04-1'}, {'id': 'SANOFI-GERCOR-SEGEMOX-S04-1'}, {'id': 'EU-20571'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'C.H.G. Beauvais', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '62200', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'Centre Hospitalier Docteur Duchenne', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'Intercommunal Hospital', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'F-51100', 'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique De Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre Rene Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '02321', 'city': 'Saint-Quentin', 'country': 'France', 'facility': 'Centre Hospitalier de Saint-Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'zip': '60309', 'city': 'Senlis', 'country': 'France', 'facility': 'C.H. Senlis', 'geoPoint': {'lat': 49.20724, 'lon': 2.58661}}, {'zip': '67065', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '83056', 'city': 'Toulon', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': 'F-94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Joseph Gligorov, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Tenon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}}}}