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dipyridamole

methotrexate

Rakesh Goel, MD, FRCPC

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and dipyridamole in treating patients with advanced ovarian cancer that is recurrent after or refractory to cisplatin-based chemotherapy.

OBJECTIVES: I. Determine the clinical complete and partial response rate, pathological complete response rate, disease-free survival, and duration of response produced by intraperitoneal dipyridamole/methotrexate (DP/MTX) administered as a 7-day continuous infusion in patients with advanced ovarian carcinoma that is recurrent following or refractory to cisplatin-based chemotherapy. II. Determine the peritoneal and systemic toxicity of DP/MTX.

OUTLINE: Nonrandomized study. Single-Agent Chemotherapy with Chemopotentiation. Methotrexate, MTX, NSC-740; with Dipyridamole, DP, NSC-515776.

PROJECTED ACCRUAL: Up to 40 evaluable patients in each category (prior intraperitoneal vs. prior intravenous platinum-based chemotherapy) will be studied. If no responses are seen in the first 20 patients in either category, accrual to that category will cease. An accrual rate of 15 patients/year is anticipated.

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA

Ottawa Regional Cancer Centre

Digestive System Diseases

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Digestive System Neoplasms

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Calcium, Dietary

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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)

200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle

fluorouracil

30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle

leucovorin calcium

10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)

mitomycin C

William H. Isacoff, MD

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.

S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer

A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma

National Cancer Institute (NCI)

SWOG Cancer Research Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer	NCT00002487	Ovarian Cancer	dipyridamole methotrexate	18 Years -	National Cancer Institute (NCI)
S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer	NCT00003018	Pancreatic Canc...	dipyridamole fluorouracil leucovorin calc... mitomycin C	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for dipyridamole

Every month we try and update this database with for dipyridamole cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.