Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT00303758
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2006-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2006-03-15', 'studyFirstSubmitQcDate': '2006-03-15', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2012'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2012'}, {'measure': 'Toxicity', 'timeFrame': '2012'}, {'measure': 'Quality of life', 'timeFrame': '2012'}, {'measure': 'Percentage of patients needing second-line therapy', 'timeFrame': '2012'}, {'measure': 'Duration of hospitalization', 'timeFrame': '2012'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the pancreas', 'recurrent pancreatic cancer', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '20947887', 'type': 'RESULT', 'citation': 'Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Federation Francophone de Cancerologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.\n\nPURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.\n\nSecondary\n\n* Compare progression-free survival of patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n* Compare the quality of life of patients treated with these regimens.\n* Compare the percentage of these patients needing second-line therapy.\n* Compare the duration of hospitalization of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.\n\nQuality of life is assessed at baseline and then every 2 months.\n\nAfter completion of study therapy, patients are followed periodically for 2 years.\n\nPROJECTED ACCRUAL: A total of 202 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 or cytologically confirmed adenocarcinoma of the pancreas or ampulla\n\n * Metastatic disease\n * Unresectable disease\n* Measurable disease, meeting the following criteria:\n\n * No prior radiotherapy to the only site of measurable disease\n * Diameter \\> 10 mm by spiral CT scan or MRI OR \\> 20 mm by conventional methods\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy \\> 2 months\n* No contraindication to chemotherapy\n* Creatinine clearance \\> 60 mL/min\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Alkaline phosphatase \\< 5 times normal\n* Bilirubin ≤ 3 mg/dL\n* No coronary insufficiency\n* No symptomatic cardiac disease\n* Good hydration possible\n* No Child-Pugh class B or C cirrhosis\n* No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix\n* Not pregnant or nursing\n* Negative pregnancy test\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior palliative or adjuvant chemotherapy\n* At least 4 weeks since prior radiotherapy\n* No radiotherapy during or for 4 weeks after study therapy\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00303758', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Federation Francophone de Cancerologie Digestive'}, 'officialTitle': 'Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression', 'orgStudyIdInfo': {'id': 'CDR0000453841'}, 'secondaryIdInfos': [{'id': 'FFCD-0301'}, {'id': 'EU-20543'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LV5FU2 simplifié + cisplatine puis gemcitabine si progression', 'description': 'LV5FU2 simplifié + cisplatine puis gemcitabine si progression', 'interventionNames': ['Drug: cisplatin', 'Drug: fluorouracil', 'Drug: gemcitabine hydrochloride', 'Drug: leucovorin calcium']}, {'type': 'EXPERIMENTAL', 'label': 'gemcitabine puis LV5FU2 simplifié + cisplatine si progression', 'description': 'gemcitabine puis LV5FU2 simplifié + cisplatine si progression', 'interventionNames': ['Drug: cisplatin', 'Drug: fluorouracil', 'Drug: gemcitabine hydrochloride', 'Drug: leucovorin calcium']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'armGroupLabels': ['LV5FU2 simplifié + cisplatine puis gemcitabine si progression', 'gemcitabine puis LV5FU2 simplifié + cisplatine si progression']}, {'name': 'fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['LV5FU2 simplifié + cisplatine puis gemcitabine si progression', 'gemcitabine puis LV5FU2 simplifié + cisplatine si progression']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['LV5FU2 simplifié + cisplatine puis gemcitabine si progression', 'gemcitabine puis LV5FU2 simplifié + cisplatine si progression']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'armGroupLabels': ['LV5FU2 simplifié + cisplatine puis gemcitabine si progression', 'gemcitabine puis LV5FU2 simplifié + cisplatine si progression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80101', 'city': 'Abbeville', 'country': 'France', 'facility': "Centre Hospitalier d'Abbeville", 'geoPoint': {'lat': 50.10521, 'lon': 1.83547}}, {'zip': '84902', 'city': 'Avignon', 'country': 'France', 'facility': 'Hopital Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '41016', 'city': 'Blois', 'country': 'France', 'facility': 'Centre Hospitalier de Blois', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': 'F-92104', 'city': 'Boulogne', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Ambroise Pare - Boulogne', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'zip': '62200', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'Centre Hospitalier Docteur Duchenne', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'C.H. Bourg En Bresse', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre Hospitalier Pierre Oudot', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Amiens", 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '51000', 'city': 'Châlons-en-Champagne', 'country': 'France', 'facility': 'Centre Hospitalier de Chalons-en-Champagne', 'geoPoint': {'lat': 48.95393, 'lon': 4.36724}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHR Clermont Ferrand, Hotel dieu', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Hopital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hopital Louis Pasteur', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '21034', 'city': 'Dijon', 'country': 'France', 'facility': 'Hopital Du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer Georges-Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '83300', 'city': 'Draguignan', 'country': 'France', 'facility': 'Centre Hospitalier Draguignan', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '59240', 'city': 'Dunkirk', 'country': 'France', 'facility': 'Centre Hospitalier De Dunkerque - 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