Ovarian Cancer Clinical Trial

ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

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.

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Full Description

OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population.

OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT00003892

Recruitment Status:

Completed

Sponsor:

NCIC Clinical Trials Group

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There are 64 Locations for this study

See Locations Near You

Duluth Clinic
Duluth Minnesota, 55805, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Lethbridge Cancer Clinic
Lethbridge Alberta, T1J 1, Canada
Burnaby Hospital Regional Cancer Centre
Burnaby British Columbia, V5H 4, Canada
Penticton Regional Hospital
Penticton British Columbia, V2A 3, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey British Columbia, V3V 1, Canada
Prostate Centre at Vancouver General Hospital
Vancouver British Columbia, V5Z 3, Canada
BC Cancer Agency
Vancouver British Columbia, V5Z 4, Canada
St. Paul's Hospital - Vancouver
Vancouver British Columbia, V6Z 1, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria British Columbia, V8R 1, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Moncton Hospital
Moncton New Brunswick, E1C 6, Canada
Doctor Leon Richard Oncology Centre
Moncton New Brunswick, E1C 8, Canada
Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
Dr. H. Bliss Murphy Cancer Centre
St. Johns Newfoundland and Labrador, A1B 3, Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia, B3H 1, Canada
Queen Elizabeth II Health Science Center
Halifax Nova Scotia, B3H 2, Canada
Royal Victoria Hospital, Barrie
Barrie Ontario, L4M 6, Canada
Peel Memorial Hospital
Brampton Ontario, L6W 2, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton Ontario, L8V 5, Canada
Kingston Regional Cancer Centre
Kingston Ontario, K7L 5, Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario, N6A 4, Canada
Trillium Health Centre
Mississauga Ontario, L5B 1, Canada
Credit Valley Hospital
Mississauga Ontario, L5M 2, Canada
York County Hospital
Newmarket Ontario, L3Y 2, Canada
North York General Hospital, Ontario
North York Ontario, M2E 1, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Ottawa Regional Cancer Center - General Division
Ottawa Ontario, K1H 8, Canada
Ottawa Regional Cancer Centre - Civic Campus
Ottawa Ontario, K1Y 4, Canada
Peterborough Oncology Clinic
Peterborough Ontario, K9H 7, Canada
Algoma District Medical Group
Sault Sainte Marie Ontario, P6B 1, Canada
Scarborough Hospital - General Site
Scarborough Ontario, M1P 2, Canada
Hotel Dieu Hospital - St. Catharines
St. Catharines Ontario, L2R 5, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury Ontario, P3E 5, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay Ontario, P7A 7, Canada
Toronto East General Hospital
Toronto Ontario, M4C 3, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
St. Michael's Hospital - Toronto
Toronto Ontario, M5B 1, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto Ontario, M5S 1, Canada
Saint Joseph's Health Centre - Toronto
Toronto Ontario, M6R 1, Canada
Humber River Regional Hospital
Weston Ontario, M9N 1, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor Ontario, N8W 2, Canada
Queen Elizabeth Hospital, PEI
Charlottetown Prince Edward Island, C1A 8, Canada
Centre Universitaire de Sante de l'Estrie
Fleurimont Quebec, J1H 5, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette Quebec, J6E 6, Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec, H1T 2, Canada
McGill University Department of Oncology
Montreal Quebec, H2W 1, Canada
Hotel Dieu de Montreal
Montreal Quebec, H2W 1, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2W-W, Canada
Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal
Montreal Quebec, H2X 3, Canada
Royal Victoria Hospital - Montreal
Montreal Quebec, H3A 1, Canada
Montreal General Hospital
Montreal Quebec, H3G 1, Canada
St. Mary's Hospital Center
Montreal Quebec, H3T 1, Canada
Queen Elizabeth Hospital, Montreal
Montreal Quebec, H4A 3, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal Quebec, H4J 1, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City Quebec, G1R 2, Canada
Hopital du Saint-Sacrament, Quebec
Quebec City Quebec, G1S 4, Canada
Hopital du Haut-Richelieu
Saint Jean-Sur-Richelieu Quebec, J3A 1, Canada
Hopital Laval
Ste-Foy Quebec, G1V 4, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Royal South Hants Hospital
Southampton England, SO14 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT00003892

Recruitment Status:

Completed

Sponsor:


NCIC Clinical Trials Group

How clear is this clinincal trial information?

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