Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
- Registration Number
- NCT00005032
- Lead Sponsor
- University of Chicago
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A paclitaxel G3139 (3 mg/kg/day continuous IV infusion over 7 days every 21 days), Paclitaxel (150 mg/m2, 3 hr IV infusion on Day 6 of every 21 day cycle) Arm A oblimersen sodium G3139 (3 mg/kg/day continuous IV infusion over 7 days every 21 days), Paclitaxel (150 mg/m2, 3 hr IV infusion on Day 6 of every 21 day cycle)
- Primary Outcome Measures
Name Time Method Tolerability of dosing 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
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
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States