NCT00003236

Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ISIS 3521
DRUG	ISIS 5132

Timeline

• Start date: 1998-07-13
• Primary completion: 2002-06-01
• First posted: 2004-06-09
• Last updated: 2023-06-18

Locations

6 sites across 1 country: United States