Pancreatic Cancer
Conditions
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.
Detailed description
OBJECTIVES: * Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer. * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.
Interventions
DRUGcisplatin
DRUGgemcitabine hydrochloride
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable adenocarcinoma of the pancreas * No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin * Prior subtotal resection or gross residual disease * No microscopic residual disease only * No metastatic disease outside of planned study radiotherapy field PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to maintain adequate oral nutrition * No significant infection * No other medical condition that would preclude study * No other malignancy within the past 5 years except non-melanoma skin cancer * No significant nausea or vomiting PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior or concurrent biologic therapy Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy that would overlap planned study radiotherapy fields Surgery: * See Disease Characteristics * At least 21 days since prior laparotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | Up to 3 years |
Countries
Canada, United States
Outcome results
None listed