NCT00003236

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 9, 2004

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3.9 years

First QC Date

November 1, 1999

Last Update Submit

June 15, 2023

Conditions

Breast Cancer

Keywords

recurrent breast cancer

Interventions

ISIS 3521BIOLOGICAL
ISIS 5132DRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, 60611, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ISIS 3521ISIS 5132

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • William J. Gradishar, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 9, 2004

Study Start

July 13, 1998

Primary Completion

June 1, 2002

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

US(6)