Clinical Trials Logo
  1. Home
  2. Ovarian Cancer
  3. NCT00003892
  4. Details
NCT00003892 Clinical Trial

ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:
Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003892
Other study ID # I116
Secondary ID CAN-NCIC-IND116C
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1, 1999
Est. completion date September 22, 2008

Study information
Verified date April 2020
Source Canadian Cancer Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date September 22, 2008
Est. primary completion date October 17, 2000
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ISIS 5132
4mg/kg/day IV for 21 days every 4 weeks.

Locations
Country Name City State
Canada Royal Victoria Hospital, Barrie Barrie Ontario
Canada Peel Memorial Hospital Brampton Ontario
Canada Burnaby Hospital Regional Cancer Centre Burnaby British Columbia
Canada Queen Elizabeth Hospital, PEI Charlottetown Prince Edward Island
Canada Cross Cancer Institute Edmonton Alberta
Canada Centre Universitaire de Sante de l'Estrie Fleurimont Quebec
Canada Nova Scotia Cancer Centre Halifax Nova Scotia
Canada Queen Elizabeth II Health Science Center Halifax Nova Scotia
Canada Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario
Canada Centre Hospitalier Regional de Lanaudiere Joliette Quebec
Canada Kingston Regional Cancer Centre Kingston Ontario
Canada Lethbridge Cancer Clinic Lethbridge Alberta
Canada Cancer Care Ontario-London Regional Cancer Centre London Ontario
Canada Credit Valley Hospital Mississauga Ontario
Canada Trillium Health Centre Mississauga Ontario
Canada Doctor Leon Richard Oncology Centre Moncton New Brunswick
Canada Moncton Hospital Moncton New Brunswick
Canada Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal Montreal Quebec
Canada Hopital Du Sacre-Coeur de Montreal Montreal Quebec
Canada Hotel Dieu de Montreal Montreal Quebec
Canada Maisonneuve-Rosemont Hospital Montreal Quebec
Canada McGill University Department of Oncology Montreal Quebec
Canada Montreal General Hospital Montreal Quebec
Canada Queen Elizabeth Hospital, Montreal Montreal Quebec
Canada Royal Victoria Hospital - Montreal Montreal Quebec
Canada St. Mary's Hospital Center Montreal Quebec
Canada York County Hospital Newmarket Ontario
Canada North York General Hospital, Ontario North York Ontario
Canada Lakeridge Health Oshawa Oshawa Ontario
Canada Ottawa Regional Cancer Center - General Division Ottawa Ontario
Canada Ottawa Regional Cancer Centre - Civic Campus Ottawa Ontario
Canada Penticton Regional Hospital Penticton British Columbia
Canada Peterborough Oncology Clinic Peterborough Ontario
Canada Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec Quebec City Quebec
Canada Hopital du Saint-Sacrament, Quebec Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Hopital du Haut-Richelieu Saint Jean-Sur-Richelieu Quebec
Canada Saint John Regional Hospital Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Algoma District Medical Group Sault Sainte Marie Ontario
Canada Scarborough Hospital - General Site Scarborough Ontario
Canada Hotel Dieu Hospital - St. Catharines St. Catharines Ontario
Canada Dr. H. Bliss Murphy Cancer Centre St. Johns Newfoundland and Labrador
Canada Hopital Laval Ste-Foy Quebec
Canada Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario
Canada British Columbia Cancer Agency - Fraser Valley Cancer Centre Surrey British Columbia
Canada Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario
Canada Mount Sinai Hospital - Toronto Toronto Ontario
Canada Princess Margaret Hospital Toronto Ontario
Canada Saint Joseph's Health Centre - Toronto Toronto Ontario
Canada St. Michael's Hospital - Toronto Toronto Ontario
Canada Toronto East General Hospital Toronto Ontario
Canada Toronto General Hospital Toronto Ontario
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
Canada Women's College Campus, Sunnybrook and Women's College Health Science Center Toronto Ontario
Canada BC Cancer Agency Vancouver British Columbia
Canada Prostate Centre at Vancouver General Hospital Vancouver British Columbia
Canada St. Paul's Hospital - Vancouver Vancouver British Columbia
Canada British Columbia Cancer Agency - Vancouver Island Cancer Centre Victoria British Columbia
Canada Humber River Regional Hospital Weston Ontario
Canada Cancer Care Ontario - Windsor Regional Cancer Centre Windsor Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
United Kingdom Royal South Hants Hospital Southampton England
United States Duluth Clinic Duluth Minnesota
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

References & 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 tr — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Toxicity To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer 9 years
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2