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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002487 |
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Date of registration:
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01/11/1999 |
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Primary sponsor: |
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Public title:
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Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer
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Scientific title:
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INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA |
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Date of first enrolment:
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July 1991 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00002487 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Rakesh Goel, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Regional Cancer Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Drug: dipyridamole
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Drug: methotrexate
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Secondary ID(s)
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CAN-OTT-9017
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CDR0000077374
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NCI-V92-0012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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