Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
OBJECTIVES:
- Confirm the value of chronomodulated infusion with respect to survival in patients with
locally advanced or metastatic pancreatic cancer.
- Test the value of adding cisplatin to fluorouracil in extending survival in these
patients.
OUTLINE: This is a multicenter, randomized study.
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment
groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in
each of the 4 groups is repeated for 3 courses where each course is a 5-day course of
treatment.
Patients in the first group receive a chronomodulated schedule based on delivery of
fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and
CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU
alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses
whereas dosages of CDDP remain constant.
Treatment is continued until disease progression, severe toxicity, or complete remission for
more than 4 months occurs.
PROJECTED ACCRUAL: 200 patients will be accrued.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a
metastasis associated with a radiologically identified pancreatic tumor
- Locally advanced and/or metastatic pancreatic cancer
- No measurable or evaluable target lesion is required
- No brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 40%-100%
Hematopoietic:
- WBC at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 3 times normal
Renal:
- Creatinine no greater than 1.24 mg/dL OR
- Creatinine clearance at least 80 mL/min
Cardiovascular:
- No overt cardiac disease
Other:
- No peripheral neuropathy
- No uncontrolled infectious or chronic disease
- No second primary except in situ carcinoma of the cervix, or basal or squamous cell
carcinoma of the skin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunologic therapy
Chemotherapy:
- No prior chemotherapy allowed
Endocrine therapy:
- No concurrent hormonal therapy
- At least 2 weeks since corticoid treatment
Radiotherapy:
- No prior radiotherapy allowed except as an analgesic treatment on metastasis
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Francis Levi, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
Authority:
United States: Federal Government
Study ID:
EORTC-05962
NCT ID:
NCT00003029
Start Date:
May 1997
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|
