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ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Phase 2
Completed
Conditions
Ovarian Cancer
Interventions
Registration Number
NCT00003892
Lead Sponsor
NCIC Clinical Trials Group
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
22
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ISIS 5132ISIS 5132ISIS 5132 x 21 days IV infusion
Primary Outcome Measures
NameTimeMethod
Objective and duration of response9 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
NameTimeMethod
Toxicity9 years

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

Trial Locations

Locations (66)

Duluth Clinic

🇺🇸

Duluth, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Cross Cancer Institute

🇨🇦

Edmonton, Alberta, Canada

Lethbridge Cancer Clinic

🇨🇦

Lethbridge, Alberta, Canada

Burnaby Hospital Regional Cancer Centre

🇨🇦

Burnaby, British Columbia, Canada

Penticton Regional Hospital

🇨🇦

Penticton, British Columbia, Canada

British Columbia Cancer Agency - Fraser Valley Cancer Centre

🇨🇦

Surrey, British Columbia, Canada

Prostate Centre at Vancouver General Hospital

🇨🇦

Vancouver, British Columbia, Canada

BC Cancer Agency

🇨🇦

Vancouver, British Columbia, Canada

St. Paul's Hospital - Vancouver

🇨🇦

Vancouver, British Columbia, Canada

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Duluth Clinic
🇺🇸Duluth, Minnesota, United States

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