Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CAN-OTT-9017 NCI-V92-0012, NCT00002487

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.

Entry 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

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

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

Expected Enrollment

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.

Outline

Nonrandomized study.

Single-Agent Chemotherapy with Chemopotentiation.  Methotrexate, MTX, NSC-740; 
with Dipyridamole, DP, NSC-515776.

Trial Contact Information

Trial Lead Organizations

Ottawa Hospital Regional Cancer Centre - General Campus

Rakesh Goel, MD, FRCPC, Protocol chair		Ph: 613-737-7700 ext. 70171; 888-627-5346 Email: rgoel@ottawahospital.on.ca

Registry Information
Official Title		INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA
Trial Start Date		1991-07-22
Registered in ClinicalTrials.gov		NCT00002487
Date Submitted to PDQ		1991-07-22
Information Last Verified		2000-04-01

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