The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Official Title: A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of Recurrent Small Cell Lung Cancer
Study ID: NCT00005032
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bcl-2 antisense oligodeoxynucleotide G3139 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase I/II trial to study the effectiveness of bcl-2 antisense oligodeoxynucleotide G3139 and paclitaxel in treating patients who have recurrent small cell lung cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Illinois at Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C., Decatur, Illinois, United States
Evanston Northwestern Health Care, Evanston, Illinois, United States
Division of Hematology/Oncology, Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C., South Bend, Indiana, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Name: Charles M. Rudin, MD, PhD
Affiliation: University of Chicago
Role: STUDY_CHAIR