ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00003892
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: July 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Objective and duration of response [ Time Frame: 9 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
    To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer


Enrollment: 22
Study Start Date: February 1999
Study Completion Date: September 2008
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISIS 5132
ISIS 5132 x 21 days IV infusion
Drug: ISIS 5132
4mg/kg/day IV for 21 days every 4 weeks.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 66 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00003892     History of Changes
Other Study ID Numbers: I116, CAN-NCIC-IND116, CDR0000067061
Study First Received: November 1, 1999
Last Updated: September 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
ISIS 5132
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014