Spots Global Cancer Trial Database for Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors. 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of G3139 in combination with carboplatin and paclitaxel. II. To determine the quantitative and qualitative nature of toxicities of G3139 with carboplatin and paclitaxel. III. To measure G3139 activity in peripheral blood lymphocytes by quantitating Bcl-2/Bax expression and transcription, as well as T-cell functioning and signaling. IV. To measure G3139 activity in tumor biopsy specimens by quantitating Bcl-2/Bax expression and transcription. V. To determine the pharmacokinetics of carboplatin, paclitaxel, and G3139, as well as intratumoral G3139 levels. VI. To screen various signal transduction pathways that may be affected by Bcl-2 down-regulation in PBMC and tumor biopsy specimens in order to better understand the mechanism of G3139 chemosensitization. VII. To seek preliminary evidence of antitumor activity for the combination of G3139, carboplatin, and paclitaxel. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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