Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	EORTC-05962 NCT00003029

Objectives

1. Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
2. Test the value of adding cisplatin to fluorouracil in extending survival in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 40%-100%

Hematopoietic:

• WBC at least 3,000/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

200 patients will be accrued.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Francis Levi, MD, PhD, Study coordinator		Ph: 33-1-45-593-855 Email: levi-f@vjf.inserm.fr

Registry Information
Official Title		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 Start Date		1997-05-01
Registered in ClinicalTrials.gov		NCT00003029
Date Submitted to PDQ		1997-05-01
Information Last Verified		2002-10-23

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