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.
cisplatin
+ fluorouracil
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: May 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
Les Cliniques Saint-Joseph ASBL
Liège, BelgiumCentre Hospitalier de la Cote Basque
Bayonne, FranceCentre Jean Perrin
Clermont-Ferrand, France