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

Unicancer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: irinotecan hydrochloride; Drug: gemcitabine hydrochloride; Drug: fluorouracil; Drug: oxaliplatin; Drug: leucovorin calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT00112658

FRE-FNCLCC-ACCORD-11/0402

EU-20512

CDR0000430100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

342 participants in 2 patient groups

Folfirinox

Experimental group

Treatment:

Drug: leucovorin calcium

Drug: irinotecan hydrochloride

Drug: fluorouracil

Drug: oxaliplatin

Gemcitabine

Active Comparator group

Treatment:

Drug: gemcitabine hydrochloride