Pancreatic Cancer
Conditions
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, duct cell adenocarcinoma of the pancreas
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.
Detailed description
OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the frequency and severity of the toxic effects associated with this therapy. IV. Assess the rate of resectability in patients who respond to therapy. OUTLINE: All patients undergo surgical placement of an indwelling central venous line. Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or complete response are reevaluated for possible surgical resection. Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every 6 months for 2 years, then annually until death. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Interventions
DRUGdipyridamole
75mg/dose, PO, Days 1-28 of 5 week cycle
DRUGfluorouracil
200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle
DRUGleucovorin calcium
30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle
DRUGmitomycin C
10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage II or III pancreatic adenocarcinoma Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed ductal-endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly differentiated adenocarcinoma Undifferentiated ductal carcinoma Must have unresectable and localized disease Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Loss of no greater than 15% of actual body weight Oral intake of greater than 1,200 calories per day No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for pancreatic cancer Surgery: At least 2 weeks since prior surgical bypass procedure and recovered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | One year |
Secondary
| Measure | Time frame |
|---|---|
| Response rate in patients with measurable disease | From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Toxicities | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Resectability of patents who respond to this regimen | From date of registration until the date of patients achieving complete or partial response assessed up to 100 months |
Countries
United States
Outcome results
None listed