Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments fluorouracil, gemcitabine hydrochloride, oxaliplatin, radiation therapy
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date November 2003
Trial identifier NCT00275119, CDR0000454568, EU-20570, GERCOR-D03-1, SANOFI-GERCOR-D03-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Progression-free survival
time frame:

Secondary Outcomes

Measure
Tolerability
time frame:
Recurrence-free survival
time frame:
Overall survival
time frame:
Response rate
time frame:
Quality of life
time frame:
Clinical benefits
time frame:
Locoregional and metastatic progression-free survival
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).