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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017251 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: etoposide Drug: oblimersen |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No active CNS disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
LaGrange Memorial Hospital | |
LaGrange, Illinois, United States, 60525 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153-5589 | |
Cancer Care Specialists of Central Illinois, S.C. | |
Decatur, Illinois, United States, 62526 | |
Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Maryland | |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Oncology Care Associates, P.L.L.C. | |
Saint Joseph, Michigan, United States, 49085 |
Study Chair: | Charles M. Rudin, MD, PhD | University of Chicago |
Study ID Numbers: | CDR0000068667, UCCRC-10992A, NCI-5110 |
Study First Received: | June 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00017251 |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carboplatin Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Etoposide Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Antineoplastic Agents, Phytogenic Pharmacologic Actions |