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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00112658
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2005
Last Update Posted : May 20, 2011
Information provided by:
National Cancer Institute (NCI)

June 2, 2005
June 3, 2005
May 20, 2011
November 2004
Not Provided
  • Objective response rate (Phase II)
  • Survival (Phase III)
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Complete list of historical versions of study NCT00112658 on Archive Site
  • Toxicity
  • Progression-free survival (Phase III)
  • Quality of life (Phase III)
  • Overall response rate (Phase III)
Not Provided
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Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

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.



  • 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.

Phase 2
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: fluorouracil
  • Drug: gemcitabine hydrochloride
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP