Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003236
First received: November 1, 1999
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521 in treating women who have metastatic breast cancer that has not responded to previous therapy.


Condition Intervention Phase
Breast Cancer
Biological: ISIS 3521
Drug: ISIS 5132
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Human C-raf Kinase Antisense Oligonucleotide Isis 5132 (CGP 69846A) or Human Pkc-Alpha Antisence Oligonucleotide ISIS 3521 (CGP 64128A) in Women With Previously Treated Matastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Study Start Date: May 1998
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Estimate the proportion of women with previously treated metastatic breast cancer who are progression free at 4 months after receiving ISIS 5132 or ISIS 3521. II. Determine duration of response to these treatment regimens in this patient population. III. Evaluate toxicities and tolerability of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of prior therapies for metastatic breast cancer (1 vs 2). Patients are randomized to one of two treatment arms. (Arm I closed 12/22/99) Arm I: Patients receive ISIS 5132 IV continuously over 21 days. (closed 12/22/99) Arm II: Patients receive ISIS 3521 IV continuously over 21 days. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. After every 2 courses, patients are evaluated for response. Patients are followed every 3 months for the first 2 years, every 6 months the next 3 years, then annually thereafter.

PROJECTED ACCRUAL: A maximum of 68 patients (34 per arm) will be accrued in this study (Arm I closed 12/22/99).

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the breast Must have failed at least one but no more than two prior therapies for metastatic breast cancer, including endocrine and chemotherapy Relapsing while receiving or within 6 months of completing adjuvant chemotherapy Disease progression during or subsequent to the most recent therapy Measurable and evaluable disease Bone is an evaluable site only No CNS metastases Hormone receptor status: Estrogen receptor negative, positive, or unknown

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Any status Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT less than 3 times upper limit of normal PTT within normal limits Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No poorly controlled hypertension At least 3 months since prior myocardial infarction Other: No history of other malignant neoplasms, except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test, documented sterilization, or postmenopausal status Fertile patients must use effective contraception No uncontrolled nonmalignant systemic diseases (including active peptic ulcer and poorly controlled diabetes mellitus) No underlying disease state associated with active bleeding No unexplained abnormality of prothrombin time (e.g., warfarin therapy)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 28 days since prior chemotherapy Endocrine therapy: See Disease Characteristics At least 28 days since prior hormonal therapy Radiotherapy: Not specified Surgery: At least 2 weeks since major surgery Other: At least 28 days since prior use of other investigational drugs No therapeutic anticoagulation with heparin

  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: NCT00003236

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: William J. Gradishar, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
Publications:
Gradishar WJ, O'Neill A, Cobleigh M, et al.: A phase II trial with antisense oligonucleotide ISIS 3521/Cgp 64128a in patients (Pts) with metastatic breast cancer (MBC): ECOG trial 3197. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-171, 2001.

ClinicalTrials.gov Identifier: NCT00003236     History of Changes
Other Study ID Numbers: CDR0000066108, ECOG-3197
Study First Received: November 1, 1999
Last Updated: August 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
ISIS 5132
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014