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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 because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112658
First received: June 2, 2005
Last updated: May 19, 2011
Last verified: December 2006
History of Changes
  Purpose

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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Objective response rate (Phase II) [ Designated as safety issue: No ]
  • Survival (Phase III) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Progression-free survival (Phase III) [ Designated as safety issue: No ]
  • Quality of life (Phase III) [ Designated as safety issue: No ]
  • Overall response rate (Phase III) [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112658

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

Publications:
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.

ClinicalTrials.gov Identifier: NCT00112658     History of Changes
Other Study ID Numbers: CDR0000430100, FRE-FNCLCC-ACCORD-11/0402, EU-20512
Study First Received: June 2, 2005
Last Updated: May 19, 2011
Health Authority: United States: Federal Government

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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Oxaliplatin
Irinotecan
Camptothecin
Leucovorin
Levoleucovorin
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013