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ABT-888 and Topotecan Hydrochloride in Treating Patients With Advanced Solid Tumors or Relapsed or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer

2014-08-27 03:18:02 | 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 topotecan hydrochloride, 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 topotecan hydrochloride may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ABT-888 together with topotecan hydrochloride and to see how well it works in treating patients with advanced solid tumors or relapsed or refractory ovarian epithelial cancer or primary peritoneal cancer.

Description

OBJECTIVES:

- To determine the maximum tolerated dose of ABT-888 and topotecan hydrochloride in patients with advanced solid tumors. (Phase I)

- To identify any pharmacokinetic interactions between ABT-888 and topotecan hydrochloride. (Phase I)

- To determine whether topotecan hydrochloride stimulates ADP-ribose polymer formation in circulating peripheral blood mononuclear cells. (Phase I)

- To determine whether ABT-888 inhibits basal or topotecan hydrochloride-stimulated ADP-ribose polymer formation. (Phase I)

- To identify any antitumor activity of this regimen, as assessed by objective response, in patients with advanced solid tumors. (Phase I)

- To assess the progression-free survival of patients with relapsed or refractory ovarian epithelial cancer or primary peritoneal cancer treated with this regimen. (Phase II)

- To assess the toxicity of this regimen in patients with ovarian epithelial cancer or primary peritoneal cancer. (Phase II)

- To determine whether topotecan hydrochloride stimulates ADP-ribose polymer formation in circulating tumor cells and whether ABT-888 modulates this. (Phase II)

- To assess differences in the toxicity and/or efficacy of this regimen based on BRCA1/2 mutational status. (Phase II)

- To determine whether pretreatment tumor cell levels of topoisomerase I, poly (ADP-ribose) polymerase, BRCA1, BRCA2, XRCC1, TDP1, P-glycoprotein, or BCRP predict response to this regimen. (Phase II)

- To identify, in an exploratory manner, any transcriptional profiles that may predict response to this regimen. (Phase II)

OUTLINE: Patients receive oral ABT-888 once daily on days 1-3, 8-10, and 15-17*. Patients also receive topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients do not receive ABT-888 on days 1-3 during course 2.

Patients undergo blood and urine sample collection periodically for pharmacokinetic, pharmacogenetic, and other correlative laboratory studies. Patients enrolled in phase II also undergo tumor tissue collection at baseline for biomarker laboratory studies.

After completion of study treatment, patients are followed up every 3-6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 104 patients (56 for phase I and 48 for phase II) will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Ovarian Cancer

Intervention

topotecan hydrochloride, veliparib, laboratory biomarker analysis, pharmacological study

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:02-0400

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Medical and Biotech [MESH] Definitions

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

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A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.

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