Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments cisplatin, docetaxel, fluorouracil, radiation therapy
Phase phase 2
Sponsor UNICANCER
Start date December 2002
Trial size 80 participants
Trial identifier NCT00112697, CDR0000430095, EU-20511, FRE-FNCLCC-ACCORD-09/0201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Progression-free survival rate at 6 months
time frame:

Secondary Outcomes

Measure
Toxicity
time frame:
Objective response rate
time frame:
Overall survival
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Description OBJECTIVES: Primary - Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy. Secondary - Compare the toxicity of these regimens in these patients. - Compare the objective response rate in patients treated with these regimens. - Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks. - Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks. In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).