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| Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054548 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs.
PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: carboplatin Drug: oblimersen Drug: paclitaxel |
Phase I |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Carboplatin Paclitaxel Oblimersen sodium |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Antisense Bcl-2 Oligonucleotide (G3139) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 55 |
| Study Start Date: | November 2002 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of oblimersen.
Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD.
PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 1 year.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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, Wisconsin | |||||
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |||||
| Madison, Wisconsin, United States, 53792-6164 | |||||
| University of Wisconsin, Madison |
| National Cancer Institute (NCI) |
| Study Chair: | Glenn Liu, MD | University of Wisconsin, Madison |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Liu G, Kolesar J, McNeel DG, Leith C, Schell K, Eickhoff J, Lee F, Traynor A, Marnocha R, Alberti D, Zwiebel J, Wilding G. A Phase I Pharmacokinetic and Pharmacodynamic Correlative Study of the Antisense Bcl-2 Oligonucleotide G3139, in Combination with Carboplatin and Paclitaxel, in Patients with Advanced Solid Tumors. Clin Cancer Res. 2008 May 1;14(9):2732-2739.
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Lalich M, Wilding G, Kolesar J, et al.: A Phase I study of antisense Bcl-2 Oligonucleotide (G3139) in combination with carboplatin (C) and paclitaxel (T) in patients with advanced solid tumors. [Abstract] J Clin Oncol 24 (Suppl 18): A-13006, 602s, 2006.
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| Study ID Numbers: | CDR0000270902, WCCC-CO-02904, NCI-5912 |
| First Received: | February 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00054548 |
| Health Authority: | United States: Food and Drug Administration |
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