search
Back to results

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
dipyridamole
methotrexate
Sponsored by
Ottawa Regional Cancer Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Regional Cancer Center - General Division
  • Ottawa Regional Cancer Centre - Civic Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 16, 2013
Sponsor
Ottawa Regional Cancer Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT00002487
Brief Title
Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer
Official Title
INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2000
Overall Recruitment Status
Unknown status
Study Start Date
July 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ottawa Regional Cancer Centre

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dipyridamole
Intervention Type
Drug
Intervention Name(s)
methotrexate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Goel, MD, FRCPC
Organizational Affiliation
Ottawa Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Ottawa Regional Cancer Center - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4K7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

We'll reach out to this number within 24 hrs