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ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ISIS 5132
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duluth Clinic
  • Memorial Sloan-Kettering Cancer Center
  • Cross Cancer Institute
  • Lethbridge Cancer Clinic
  • Burnaby Hospital Regional Cancer Centre
  • Penticton Regional Hospital
  • British Columbia Cancer Agency - Fraser Valley Cancer Centre
  • Prostate Centre at Vancouver General Hospital
  • BC Cancer Agency
  • St. Paul's Hospital - Vancouver
  • British Columbia Cancer Agency - Vancouver Island Cancer Centre
  • CancerCare Manitoba
  • Moncton Hospital
  • Doctor Leon Richard Oncology Centre
  • Saint John Regional Hospital
  • Dr. H. Bliss Murphy Cancer Centre
  • Nova Scotia Cancer Centre
  • Queen Elizabeth II Health Science Center
  • Royal Victoria Hospital, Barrie
  • Peel Memorial Hospital
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Kingston Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Trillium Health Centre
  • Credit Valley Hospital
  • York County Hospital
  • North York General Hospital, Ontario
  • Lakeridge Health Oshawa
  • Ottawa Regional Cancer Center - General Division
  • Ottawa Regional Cancer Centre - Civic Campus
  • Peterborough Oncology Clinic
  • Algoma District Medical Group
  • Scarborough Hospital - General Site
  • Hotel Dieu Hospital - St. Catharines
  • Northeastern Ontario Regional Cancer Centre, Sudbury
  • Northwestern Ontario Regional Cancer Centre, Thunder Bay
  • Toronto East General Hospital
  • Toronto Sunnybrook Regional Cancer Centre
  • St. Michael's Hospital - Toronto
  • Mount Sinai Hospital - Toronto
  • Toronto General Hospital
  • Princess Margaret Hospital
  • Women's College Campus, Sunnybrook and Women's College Health Science Center
  • Saint Joseph's Health Centre - Toronto
  • Humber River Regional Hospital
  • Cancer Care Ontario - Windsor Regional Cancer Centre
  • Queen Elizabeth Hospital, PEI
  • Centre Universitaire de Sante de l'Estrie
  • Centre Hospitalier Regional de Lanaudiere
  • Maisonneuve-Rosemont Hospital
  • McGill University Department of Oncology
  • Hotel Dieu de Montreal
  • Centre Hospitalier de l'Universite de Montreal
  • Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal
  • Royal Victoria Hospital - Montreal
  • Montreal General Hospital
  • St. Mary's Hospital Center
  • Queen Elizabeth Hospital, Montreal
  • Hopital Du Sacre-Coeur de Montreal
  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
  • Hopital du Saint-Sacrament, Quebec
  • Hopital du Haut-Richelieu
  • Hopital Laval
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Royal South Hants Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISIS 5132

Arm Description

ISIS 5132 x 21 days IV infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Toxicity
To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer

Full Information

First Posted
November 1, 1999
Last Updated
April 2, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00003892
Brief Title
ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
Official Title
Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 1999 (Actual)
Primary Completion Date
October 17, 2000 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISIS 5132
Arm Type
Experimental
Arm Description
ISIS 5132 x 21 days IV infusion
Intervention Type
Drug
Intervention Name(s)
ISIS 5132
Intervention Description
4mg/kg/day IV for 21 days every 4 weeks.
Primary Outcome Measure Information:
Title
Objective and duration of response
Description
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.
Time Frame
9 years
Secondary Outcome Measure Information:
Title
Toxicity
Description
To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer
Time Frame
9 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit M. Oza, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Lethbridge Cancer Clinic
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1J 1W5
Country
Canada
Facility Name
Burnaby Hospital Regional Cancer Centre
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5H 4C2
Country
Canada
Facility Name
Penticton Regional Hospital
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 3G6
Country
Canada
Facility Name
British Columbia Cancer Agency - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Prostate Centre at Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
St. Paul's Hospital - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6ZB
Country
Canada
Facility Name
Doctor Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Queen Elizabeth II Health Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Royal Victoria Hospital, Barrie
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Peel Memorial Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6W 2Z8
Country
Canada
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
York County Hospital
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
North York General Hospital, Ontario
City
North York
State/Province
Ontario
ZIP/Postal Code
M2E 1K1
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Ottawa Regional Cancer Center - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4K7
Country
Canada
Facility Name
Peterborough Oncology Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 7B6
Country
Canada
Facility Name
Algoma District Medical Group
City
Sault Sainte Marie
State/Province
Ontario
ZIP/Postal Code
P6B 1Y5
Country
Canada
Facility Name
Scarborough Hospital - General Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
Facility Name
Hotel Dieu Hospital - St. Catharines
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 5K3
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre, Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Northwestern Ontario Regional Cancer Centre, Thunder Bay
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 7T1
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E9
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Women's College Campus, Sunnybrook and Women's College Health Science Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B6
Country
Canada
Facility Name
Saint Joseph's Health Centre - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Cancer Care Ontario - Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Queen Elizabeth Hospital, PEI
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
Facility Name
Centre Universitaire de Sante de l'Estrie
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre Hospitalier Regional de Lanaudiere
City
Joliette
State/Province
Quebec
ZIP/Postal Code
J6E 6J2
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Department of Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hotel Dieu de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W-W1T8
Country
Canada
Facility Name
Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Royal Victoria Hospital - Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
St. Mary's Hospital Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
Queen Elizabeth Hospital, Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3L6
Country
Canada
Facility Name
Hopital Du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Hopital du Saint-Sacrament, Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Hopital du Haut-Richelieu
City
Saint Jean-Sur-Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1B7
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12694666
Citation
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.
Results Reference
result

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ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

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