A Phase 2 interventional study of dipyridamole and fluorouracil in Pancreatic Cancer, sponsored by SWOG Cancer Research Network. Completed at 84 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-03.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 54 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
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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
dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
Drug: dipyridamole · Drug: fluorouracil · Drug: leucovorin calcium · Drug: mitomycin C
75mg/dose, PO, Days 1-28 of 5 week cycle
Also known as: Persantine, NSC-515776
200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle
Also known as: 5-fluorouracil, 5-FU, NSC-19893
30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle
Also known as: NSC-3590
10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
Also known as: Mutamycin, NSC-26980
Overall Survival
Time frame: One year
Response rate in patients with measurable disease
Time frame: 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
Time frame: 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
Time frame: From date of registration until the date of patients achieving complete or partial response assessed up to 100 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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