ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003892

Collaborator

(none)

Enrollment

Locations

Arm

115.7

Actual Duration (Months)

0.3

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: ISIS 5132	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 1999

Actual Primary Completion Date :

Oct 17, 2000

Actual Study Completion Date :

Sep 22, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ISIS 5132 ISIS 5132 x 21 days IV infusion	Drug: ISIS 5132 4mg/kg/day IV for 21 days every 4 weeks.

Arm

Intervention/Treatment

Experimental: ISIS 5132

ISIS 5132 x 21 days IV infusion

Drug: ISIS 5132

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

Outcome Measures

Primary Outcome Measures

Objective and duration of response [9 years]
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 [9 years]
To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duluth Clinic	Duluth	Minnesota	United States	55805
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
3	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
4	Lethbridge Cancer Clinic	Lethbridge	Alberta	Canada	T1J 1W5
5	Burnaby Hospital Regional Cancer Centre	Burnaby	British Columbia	Canada	V5H 4C2
6	Penticton Regional Hospital	Penticton	British Columbia	Canada	V2A 3G6
7	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia	Canada	V3V 1Z2
8	Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 3J5
9	BC Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
10	St. Paul's Hospital - Vancouver	Vancouver	British Columbia	Canada	V6Z 1Y6
11	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Victoria	British Columbia	Canada	V8R 1J8
12	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
13	Moncton Hospital	Moncton	New Brunswick	Canada	E1C 6ZB
14	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick	Canada	E1C 8X3
15	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
16	Dr. H. Bliss Murphy Cancer Centre	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
17	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
18	Queen Elizabeth II Health Science Center	Halifax	Nova Scotia	Canada	B3H 2Y9
19	Royal Victoria Hospital, Barrie	Barrie	Ontario	Canada	L4M 6M2
20	Peel Memorial Hospital	Brampton	Ontario	Canada	L6W 2Z8
21	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
22	Kingston Regional Cancer Centre	Kingston	Ontario	Canada	K7L 5P9
23	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
24	Trillium Health Centre	Mississauga	Ontario	Canada	L5B 1B8
25	Credit Valley Hospital	Mississauga	Ontario	Canada	L5M 2N1
26	York County Hospital	Newmarket	Ontario	Canada	L3Y 2P9
27	North York General Hospital, Ontario	North York	Ontario	Canada	M2E 1K1
28	Lakeridge Health Oshawa	Oshawa	Ontario	Canada	L1G 2B9
29	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario	Canada	K1H 8L6
30	Ottawa Regional Cancer Centre - Civic Campus	Ottawa	Ontario	Canada	K1Y 4K7
31	Peterborough Oncology Clinic	Peterborough	Ontario	Canada	K9H 7B6
32	Algoma District Medical Group	Sault Sainte Marie	Ontario	Canada	P6B 1Y5
33	Scarborough Hospital - General Site	Scarborough	Ontario	Canada	M1P 2V5
34	Hotel Dieu Hospital - St. Catharines	St. Catharines	Ontario	Canada	L2R 5K3
35	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario	Canada	P3E 5J1
36	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario	Canada	P7A 7T1
37	Toronto East General Hospital	Toronto	Ontario	Canada	M4C 3E9
38	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
39	St. Michael's Hospital - Toronto	Toronto	Ontario	Canada	M5B 1W8
40	Mount Sinai Hospital - Toronto	Toronto	Ontario	Canada	M5G 1X5
41	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
42	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
43	Women's College Campus, Sunnybrook and Women's College Health Science Center	Toronto	Ontario	Canada	M5S 1B6
44	Saint Joseph's Health Centre - Toronto	Toronto	Ontario	Canada	M6R 1B5
45	Humber River Regional Hospital	Weston	Ontario	Canada	M9N 1N8
46	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
47	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island	Canada	C1A 8T5
48	Centre Universitaire de Sante de l'Estrie	Fleurimont	Quebec	Canada	J1H 5N4
49	Centre Hospitalier Regional de Lanaudiere	Joliette	Quebec	Canada	J6E 6J2
50	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4
51	McGill University Department of Oncology	Montreal	Quebec	Canada	H2W 1S6
52	Hotel Dieu de Montreal	Montreal	Quebec	Canada	H2W 1T8
53	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2W-W1T8
54	Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal	Montreal	Quebec	Canada	H2X 3J4
55	Royal Victoria Hospital - Montreal	Montreal	Quebec	Canada	H3A 1A1
56	Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4
57	St. Mary's Hospital Center	Montreal	Quebec	Canada	H3T 1M5
58	Queen Elizabeth Hospital, Montreal	Montreal	Quebec	Canada	H4A 3L6
59	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec	Canada	H4J 1C5
60	Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec	Quebec City	Quebec	Canada	G1R 2J6
61	Hopital du Saint-Sacrament, Quebec	Quebec City	Quebec	Canada	G1S 4L8
62	Hopital du Haut-Richelieu	Saint Jean-Sur-Richelieu	Quebec	Canada	J3A 1B7
63	Hopital Laval	Ste-Foy	Quebec	Canada	G1V 4G5
64	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
65	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4
66	Royal South Hants Hospital	Southampton	England	United Kingdom	SO14 0YG

Sponsors and Collaborators

NCIC Clinical Trials Group

Investigators

Study Chair: Amit M. Oza, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NCIC Clinical Trials Group

ClinicalTrials.gov Identifier:

NCT00003892

Other Study ID Numbers:

I116
CAN-NCIC-IND116
CDR0000067061

First Posted:

Aug 5, 2004

Last Update Posted:

Apr 6, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by NCIC Clinical Trials Group

stage IV ovarian epithelial cancer

recurrent ovarian epithelial cancer

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

ISIS 5132

Study Results

No Results Posted as of Apr 6, 2020