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INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Rakesh Goel, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Ottawa Regional Cancer Centre

Authority:

United States: Federal Government

Study ID:

CDR0000077374

NCT ID:

NCT00002487

Start Date:

July 1991

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

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