Overview

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ottawa Regional Cancer Centre
Treatments:
Dipyridamole
Methotrexate
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