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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective and duration of response

Outcome 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.

Outcome Time Frame:

9 years

Safety Issue:

No

Principal Investigator

Amit M. Oza, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

I116

NCT ID:

NCT00003892

Start Date:

February 1999

Completion Date:

September 2008

Related Keywords:

  • Ovarian Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Duluth Clinic Duluth, Minnesota  55805