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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 200
- Locations
- 19
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
- •Bilirubin no greater than 3 times normal
- •Creatinine no greater than 1.24 mg/dL OR
- •Creatinine clearance at least 80 mL/min
- •Cardiovascular:
- •No overt cardiac disease
- •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
- •Not specified
Exclusion Criteria
- Not provided