A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of Recurrent Small Cell Lung Cancer
OBJECTIVES: I. Assess the toxicity and feasibility of paclitaxel administration during
continuous intravenous bcl-2 antisense oligodeoxynucleotide G3139 in patients with recurrent
small cell lung cancer. II. Evaluate the clinical response of this patient population when
treated with this regimen. III. Evaluate the correlation between bcl-2 expression in these
patients and efficacy of this therapy.
OUTLINE: Patients are stratified according to whether they have received prior taxane
therapy (yes vs no). Patients receive bcl-2 antisense oligodeoxynucleotide G3139 IV
continuously on days 1-6 followed by 2 weeks of rest. Paclitaxel IV is administered over 3
hours on day 6 of each course. Treatment continues for a minimum of 2 courses in the absence
of disease progression or unacceptable toxicity. Intrapatient dose escalation is allowed.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 12-18
months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability of dosing
3 years
Yes
Charles M. Rudin, MD, PhD
Study Chair
University of Chicago
United States: Federal Government
10117
NCT00005032
April 2000
September 2001
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Division of Hematology/Oncology | Park Ridge, Illinois 60068 |