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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: docetaxel
* Drug: fluorouracil
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: docetaxel<br> <br> Drug: fluorouracil<br> <br> Radiation: radiation therapy<br> <br> |
| Experimental: Arm 2<br> | Drug: cisplatin<br> <br> Drug: docetaxel<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Objective response rate |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the pancreas, stage IV pancreatic cancer