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
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Laurence Moureau-Zabotto, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Paoli-Calmettes
Authority:
United States: Federal Government
Study ID:
CDR0000454568
NCT ID:
NCT00275119
Start Date:
November 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage II pancreatic cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- Pancreatic Neoplasms
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