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Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors

2014-08-27 03:55:28 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

- Determine the maximum tolerated dose of oblimersen when administered in combination with carboplatin and paclitaxel in patients with advanced solid tumors.

- Determine the quantitative and qualitative toxic effects of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine, preliminarily, the antitumor activity of this regimen in these patients.

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.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

oblimersen sodium, carboplatin, paclitaxel

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison
Wisconsin
United States
53792-6164

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:28-0400

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Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

An organoplatinum compound that possesses antineoplastic activity.

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

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