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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 2, 2005
Last updated: May 19, 2011
Last verified: December 2006

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.

Condition Intervention Phase
Pancreatic Cancer
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (Phase II)
  • Survival (Phase III)

Secondary Outcome Measures:
  • Toxicity
  • Progression-free survival (Phase III)
  • Quality of life (Phase III)
  • Overall response rate (Phase III)

Estimated Enrollment: 348
Study Start Date: November 2004
Detailed Description:



  • 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)


  • 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 75

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)


  • Creatinine < 120 mmol/L


  • No prior myocardial infarction
  • No prior angina
  • No uncompensated cardiac or coronary insufficiency
  • No symptomatic arrhythmia


  • No prior inflammatory bowel disease
  • No prior chronic diarrhea
  • No unresolved symptomatic occlusion or subocclusion of the bowel


  • 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


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • Not specified


  • No concurrent participation in another clinical trial using therapeutic experimental agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00112658

  Show 55 Study Locations
Sponsors and Collaborators
Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
  More Information

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. Identifier: NCT00112658     History of Changes
Other Study ID Numbers: CDR0000430100
Study First Received: June 2, 2005
Last Updated: May 19, 2011

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Protective Agents processed this record on April 28, 2017