Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

September 16, 2013 updated by: Ottawa Regional Cancer Centre

INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4K7
        • Ottawa Regional Cancer Centre - Civic Campus
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Regional Cancer Center - General Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Regional Cancer Centre

Investigators

  • Study Chair: Rakesh Goel, MD, FRCPC, Ottawa Regional Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1991

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 27, 2004

First Posted (Estimate)

August 30, 2004

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

April 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000077374
  • CAN-OTT-9017
  • NCI-V92-0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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