Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Tracking Information
First Submitted Date ICMJE	June 2, 2005
First Posted Date ICMJE	June 3, 2005
Last Update Posted Date	May 20, 2011
Study Start Date ICMJE	November 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: April 9, 2007)	Objective response rate (Phase II); Survival (Phase III)
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00112658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 9, 2007)	Toxicity; Progression-free survival (Phase III); Quality of life (Phase III); Overall response rate (Phase III)
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Official Title ICMJE	Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Brief Summary	RATIONALE: Drugs used in chemotherapy 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) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer. PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.
Detailed Description	OBJECTIVES: Primary; Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II); Compare the survival of patients treated with these regimens. (Phase III) Secondary; Compare the toxicity of these regimens in these patients.; Compare progression-free survival of patients treated with these regimens. (Phase III); Compare the overall response rate in patients treated with these regimens. (Phase III); Compare quality of life of patients treated with these regimens. (Phase III) OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.; Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days.; Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days. PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Primary Purpose: Treatment
Condition ICMJE	Pancreatic Cancer
Intervention ICMJE	Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin
Study Arms	Not Provided
Publications *	Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.; Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.; Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: November 8, 2006)	348
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas No other pancreatic tumor type, including either of the following: Neuroendocrine tumor Acinar cell tumor Metastatic disease; Measurable disease in an area not previously irradiated; No cerebral metastases or meningeal involvement of the tumor PATIENT CHARACTERISTICS: Age; 18 to 75 Performance status; WHO 0-1 Life expectancy; Not specified Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3 Hepatic; Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed) Renal; Creatinine < 120 mmol/L Cardiovascular; No prior myocardial infarction; No prior angina; No uncompensated cardiac or coronary insufficiency; No symptomatic arrhythmia Gastrointestinal; No prior inflammatory bowel disease; No prior chronic diarrhea; No unresolved symptomatic occlusion or subocclusion of the bowel Other; Not pregnant or nursing; Fertile patients must use effective contraception; No ongoing active infection; No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No contraindication to study treatment; No other serious medical disorder that would preclude study treatment; No psychiatric disorder or social or geographic situation that would preclude study participation; Not detained or under the guardianship of another person PRIOR CONCURRENT THERAPY: Biologic therapy; Not specified Chemotherapy; No prior chemotherapy Endocrine therapy; Not specified Radiotherapy; No prior radiotherapy Surgery; Not specified Other; No concurrent participation in another clinical trial using therapeutic experimental agents
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00112658
Other Study ID Numbers ICMJE	CDR0000430100; FRE-FNCLCC-ACCORD-11/0402; EU-20512
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	UNICANCER
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
PRS Account	National Cancer Institute (NCI)
Verification Date	December 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP