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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017251 |
Purpose
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 |
Biological: oblimersen sodium Drug: carboplatin Drug: etoposide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Cancer Care Specialists of Central Illinois, S.C. | |
| Decatur, Illinois, United States, 62526 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5589 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00017251 History of Changes |
| Other Study ID Numbers: | CDR0000068667, UCCRC-10992A, NCI-5110 |
| Study First Received: | June 6, 2001 |
| Last Updated: | April 4, 2009 |
| Health Authority: | United States: Federal Government |
|
extensive stage small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Etoposide Etoposide phosphate Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |