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 Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed 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
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Compare the toxicity of these regimens in these patients.
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Compare the objective response rate in patients treated with these regimens.
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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.
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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.
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1
|
Drug: docetaxel
Drug: fluorouracil
Radiation: radiation therapy
|
Experimental: Arm 2
|
Drug: cisplatin
Drug: docetaxel
Radiation: radiation therapy
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival rate at 6 months []
Secondary Outcome Measures
- Toxicity []
- Objective response rate []
- Overall survival []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed adenocarcinoma of the pancreas
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No other pancreatic tumor type, including either of the following:
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Neuroendocrine tumor
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Ampulla of Vater carcinoma
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Metastatic disease
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Measurable or evaluable disease
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Unresectable disease, defined as either of the following:
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Failed prior attempt of surgical resection by laparotomy
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Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)
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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
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Platelet count ≥ 100,000/mm^3
Hepatic
-
Bilirubin < 1.5 times upper limit of normal
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No hepatic disturbance
Renal
- Creatinine < 120 mmol/L
Cardiovascular
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No untreated cardiac or coronary insufficiency
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No uncontrolled symptomatic arrhythmia
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No uncontrolled angina
Pulmonary
- No uncontrolled respiratory insufficiency
Other
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Not pregnant or nursing
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Fertile patients must use effective contraception
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No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
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No peripheral neuropathy ≥ grade 2
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No ongoing active infection
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Centre Paul Papin | Angers | France | 49036 | |
2 | Centre Oscar Lambret | Lille | France | 59020 | |
3 | Polyclinique des Quatre Pavillons | Lormont | France | 33310 | |
4 | Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | France | 13273 | |
5 | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | France | 34298 | |
6 | Centre Regional Rene Gauducheau | Nantes-Saint Herblain | France | 44805 | |
7 | Centre Hospitalier Lyon Sud | Pierre Benite | France | 69495 | |
8 | Centre Rene Huguenin | Saint Cloud | France | 92210 | |
9 | Centre Alexis Vautrin | Vandoeuvre-les-Nancy | France | 54511 | |
10 | Institut Gustave Roussy | Villejuif | France | F-94805 |
Sponsors and Collaborators
- UNICANCER
Investigators
- Study Chair: Michel Ducreux, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000430095
- FRE-FNCLCC-ACCORD-09/0201
- EU-20511