Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over		CAN-NCIC-IND116 NCT00003892, IND116

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.

Entry 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

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 
 

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

Expected Enrollment

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

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.

Oza AM, Elit L, Swenerton K, et al.: Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND.116). Gynecol Oncol 89 (1): 129-33, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Amit Oza, MD, Protocol chair		Ph: 416-946-2818

Registry Information
Official Title		Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer
Trial Start Date		1999-02-01
Registered in ClinicalTrials.gov		NCT00003892
Date Submitted to PDQ		1999-05-06
Information Last Verified		2000-07-01

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