ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

NCT00003892 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: I116CAN-NCIC-IND116CDR0000067061
• Study Type: interventional
• Target: 22
• Locations: 3 countries
• Sites: 66

Brief 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.

Conditions

Ovarian Cancer

Keywords

stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Objective and duration of response

  To determine the efficacy of ISIS 5132 in patients with recurrent epithelial ovarian cancer, with evaluation of objective responses and duration of responses in patients receiving this compound in a phase II trial.

  9 years

Secondary Outcomes (1)

• Toxicity

  9 years

Study Arms (1)

ISIS 5132

EXPERIMENTAL

ISIS 5132 x 21 days IV infusion

Drug: ISIS 5132

Interventions

ISIS 5132 DRUG

4mg/kg/day IV for 21 days every 4 weeks.

ISIS 5132

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (66)

Duluth Clinic

Duluth, Minnesota, 55805, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Lethbridge Cancer Clinic

Lethbridge, Alberta, T1J 1W5, Canada

Location

Burnaby Hospital Regional Cancer Centre

Burnaby, British Columbia, V5H 4C2, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

British Columbia Cancer Agency - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 1J8, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Queen Elizabeth II Health Science Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Royal Victoria Hospital, Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

Peel Memorial Hospital

Brampton, Ontario, L6W 2Z8, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

York County Hospital

Newmarket, Ontario, L3Y 2P9, Canada

Location

North York General Hospital, Ontario

North York, Ontario, M2E 1K1, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Regional Cancer Center - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Regional Cancer Centre - Civic Campus

Ottawa, Ontario, K1Y 4K7, Canada

Location

Peterborough Oncology Clinic

Peterborough, Ontario, K9H 7B6, Canada

Location

Algoma District Medical Group

Sault Ste. Marie, Ontario, P6B 1Y5, Canada

Location

Scarborough Hospital - General Site

Scarborough Village, Ontario, M1P 2V5, Canada

Location

Hotel Dieu Hospital - St. Catharines

St. Catharines, Ontario, L2R 5K3, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E9, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Women's College Campus, Sunnybrook and Women's College Health Science Center

Toronto, Ontario, M5S 1B6, Canada

Location

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Queen Elizabeth Hospital, PEI

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

Centre Universitaire de Sante de l'Estrie

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Regional de Lanaudiere

Joliette, Quebec, J6E 6J2, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Hotel Dieu de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W-W1T8, Canada

Location

Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal

Montreal, Quebec, H2X 3J4, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Queen Elizabeth Hospital, Montreal

Montreal, Quebec, H4A 3L6, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hopital du Saint-Sacrament, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

Hopital du Haut-Richelieu

Saint-Jean-sur-Richelieu, Quebec, J3A 1B7, Canada

Location

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Related Publications (1)

• Oza AM, Elit L, Swenerton K, Faught W, Ghatage P, Carey M, McIntosh L, Dorr A, Holmlund JT, Eisenhauer E; NCIC Clinical Trials Group Study (NCIC IND.116). Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND.116). Gynecol Oncol. 2003 Apr;89(1):129-33. doi: 10.1016/s0090-8258(02)00144-0.

  PMID: 12694666 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

ISIS 5132

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Amit M. Oza, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 5, 2004
• Study Start: February 1, 1999
• Primary Completion: October 17, 2000
• Study Completion: September 22, 2008
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); GB (1); CA (63)