Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00275119

CDR0000454568

GERCOR-D03-1

EU-20570

SANOFI-GERCOR-D03-1

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Full description

OBJECTIVES:

Primary

• Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.

Secondary

• Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
• Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
• Determine the quality of life of patients treated with this regimen.
• Determine the clinical benefits of this regimen in these patients.
• Determine locoregional and metastatic progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

• Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.
• Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas

  • Locally advanced, nonresectable disease
  • Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery

• No visceral or peritoneal metastases

• No adenocarcinoma of the bile ducts or the ampulla of Vater

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Stable or controlled pain with analgesics
• Not pregnant or nursing
• Neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times normal OR < 3 mg/dL
• Creatinine clearance ≥ 40 mL/min
• Bilirubin ≤ 1.5 times normal
• Alkaline phosphatase < 5 times normal
• No medical condition that would preclude study treatment
• No active infection
• Negative pregnancy test
• No serious cardiac or respiratory disease
• No uncontrolled or persistent hypercalcemia
• No pre-existing neuropathy
• No biliary or gastro-duodenal obstruction
• No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
• No familial, social, geographical, or psychological condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
• At least 2 months since prior radiotherapy