Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• No other pancreatic tumor type, including either of the following:

• Neuroendocrine tumor

• Ampulla of Vater carcinoma

• Metastatic disease

• Measurable or evaluable disease

• Unresectable disease, defined as either of the following:

• Failed prior attempt of surgical resection by laparotomy

• Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)

• No cerebral metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < 1.5 times upper limit of normal

• No hepatic disturbance

Renal

• Creatinine < 120 mmol/L

Cardiovascular

• No untreated cardiac or coronary insufficiency

• No uncontrolled symptomatic arrhythmia

• No uncontrolled angina

Pulmonary

• No uncontrolled respiratory insufficiency

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix

• No peripheral neuropathy ≥ grade 2

• No ongoing active infection

• No other serious uncontrolled medical disorder that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the celiac or pancreatic area

Surgery

• See Disease Characteristics