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ABT-888, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer

2014-07-24 14:20:17 | BioPortfolio

Summary

RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with carboplatin and paclitaxel may help kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given together with carboplatin and paclitaxel in treating patients with advanced solid cancer.

Description

OBJECTIVES:

Primary

- To determine the recommended dose for phase II studies of ABT-888 that can be administered in combination with carboplatin and paclitaxel in patients with advanced solid malignancies. (Part A)

- To determine the recommended dose for phase II studies of ABT-888 that can be administered in combination with carboplatin and paclitaxel in patients with advanced solid malignancies that harbor a germline BRCA1/2 mutation. (Part B) (added 04/07/09)

Secondary

- To define the dose-limiting toxicity and other toxicities associated with the use of this combination.

- To obtain preliminary evidence of antitumor activity in patients treated with this combination.

- To evaluate the pharmacokinetic parameters of ABT-888, carboplatin, and paclitaxel when administered as a combination.

- To conduct correlative science studies including determination of the effect of ABT-888 on carboplatin-induced DNA adduct formation in tumor specimens.

OUTLINE:

- Part A (advanced solid tumors): Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 in course 1. Beginning in course 2 and all subsequent courses, patients receive escalating doses of oral ABT-888 twice daily on days 1-7 until the recommended phase II dose is determined. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 3. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.

- Part B (advanced solid tumors/germline BRCA 1 or 2 mutation)(added 04/07/09): Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 3, and oral ABT-888 twice daily on days 1-7 until the recommended phase II dose is determined. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo peripheral blood mononuclear cell collection periodically for pharmacokinetic studies, evaluation of DNA adducts, and Poly-ADP ribose (PAR) levels. Some patients undergo tumor biopsies to evaluate the intratumoral effects of this regimen.

After completion of study treatment, patients are followed for 4 weeks.

Study Design

Primary Purpose: Treatment

Conditions

brca1 Mutation Carrier

Intervention

carboplatin, paclitaxel, veliparib

Location

City of Hope Comprehensive Cancer Center
Duarte
California
United States
91010-3000

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:20:17-0400

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Medical and Biotech [MESH] Definitions

The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Autosomal dominant HEREDITARY CANCER SYNDROME in which a mutation most often in either BRCA1 or BRCA2 is associated with a significantly increased risk for breast and ovarian cancers.

An enzyme of long-chain fatty acid synthesis, that adds a two-carbon unit from malonyl-(acyl carrier protein) to another molecule of fatty acyl-(acyl carrier protein), giving a beta-ketoacyl-(acyl carrier protein) with the release of carbon dioxide. EC 2.3.1.41.

An organoplatinum compound that possesses antineoplastic activity.

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