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Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002487
Recruitment Status : Unknown
Verified April 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2004
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: dipyridamole Drug: methotrexate Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : July 1991

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven, Stage III/IV ovarian carcinoma that is refractory or recurrent within 1 year of complete response to intraperitoneal or intravenous platinum-based chemotherapy Debulking surgery must have been considered at the completion of prior chemotherapy (failure to debulk does not exclude) Clinical or radiographic evidence of advanced, predominantly peritoneal disease on physical exam, CT or MRI scan, exploratory laparotomy, or peritoneal cytology or by elevated CA-125 (above 35 units in Ottawa Civic or General Hospitals) required Disease limited to peritoneal cavity not required, but peritoneal disease should constitute the main life-threatening or symptom-producing component Good distribution of contrast medium throughout peritoneal cavity on CT of abdomen and pelvis required Measurable, evaluable, or unevaluable disease of any size acceptable

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 2 months Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 3 X ULN SGOT less than 3 x ULN Renal: Creatinine less than 1.7 mg/dl (150 micromoles/liter) BUN less than 42 mg/dl (15 mmoles/liter) Other: No requirement for DP or MTX or any medication known to interact with DP, (i.e., antiplatelet or anticoagulant drugs) or MTX (i.e., chemotherapeutic agents) No second malignancy other than basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Recovery from toxicities of prior therapy required Biologic therapy: Not specified Chemotherapy: Prior platinum-based chemotherapy required No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior abdominopelvic or pelvic radiotherapy No concurrent peritoneal radiotherapy Surgery: See Disease Characteristics Other: No concurrent antiplatelet or vasodilatory agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002487

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Canada, Ontario
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada, K1H 8L6
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, Canada, K1Y 4K7
Sponsors and Collaborators
Ottawa Regional Cancer Centre
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Study Chair: Rakesh Goel, MD, FRCPC Ottawa Regional Cancer Centre
Layout table for additonal information Identifier: NCT00002487    
Other Study ID Numbers: CDR0000077374
First Posted: August 30, 2004    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: April 2000
Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors