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ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003892
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: ISIS 5132
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: ISIS 5132
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: February 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003892

  Show 66 Study Locations
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000067061, CAN-NCIC-IND116
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003892  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
ISIS 5132
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009