ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 2008-09-22
• 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.

PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: ISIS 5132

Criteria

DISEASE CHARACTERISTICS: Histologically documented ovarian epithelial cancer Metastatic and/or locally recurrent disease that is incurable with standard therapy Must have received 1 or 2 prior regimens of chemotherapy At least 1 regimen must have contained cisplatin or carboplatin Bidimensionally measurable disease Indicator lesion size must be as follows: At least 4-50 cm2 by CT scan At least 1 cm2 by chest xray At least 1 cm2 (e.g., nodules) by physical exam No abdominal adenocarcinoma of unknown origin No borderline ovarian tumor No tumor known to be of primary fallopian tube or peritoneal origin

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 No known bleeding disorder Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST less than 5 times ULN PT/PTT normal (except when elevated due to therapeutic coumadin) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No significant cardiac dysfunction Neurologic No history of significant neurologic disorder No significant psychiatric disorder Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy and no evidence of recurrence No other serious illness or medical condition No active uncontrolled infection No complete bowel obstruction

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy At least 4 weeks since radiotherapy to at least 20% of bone marrow Surgery: Not specified Other: As least 28 days since prior investigational agent or new anticancer therapy No concurrent therapeutic heparin No other concurrent investigational therapy