Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00075452

FRE-GERCOR-GEM-GEMOX/D00-3

CDR0000346480

EU-20324

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Full description

OBJECTIVES:

Primary

Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

Compare the time of response in patients treated with these regimens.
Compare the clinical benefit of and tolerance to these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
Compare the progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed pancreatic adenocarcinoma
- Locally advanced or metastatic disease
- Unresectable disease
Measurable disease
- At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
No adenocarcinoma of the bile ducts or ampulla of Vater
No known brain metastases

PATIENT CHARACTERISTICS:

Age

18 to 75

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

More than 12 weeks

Hematopoietic

Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic

Bilirubin less than 1.5 times normal
Alkaline phosphatase less than 5 times normal

Renal

Creatinine less than 1.5 times normal
No uncontrolled or persistent hypercalcemia

Cardiovascular

No serious cardiac failure

Pulmonary

No serious respiratory failure

Other

Pain must be stabilized or controlled before initiation of study treatment
Not pregnant or nursing
Fertile patients must use effective contraception
No other untreatable malignant tumor
No serious psychological, familial, social, or geographical condition that would preclude study participation
No neuropathy that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy