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Spots Global Cancer Trial Database for Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

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Trial Identification

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

Conditions

Lung Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Charles M. Rudin, MD, PhD

Affiliation: University of Chicago

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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