Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors

NCT01233505 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-04-02

No results posted yet for this study

Summary

This phase I trial is studying the side effects and the best dose of veliparib when given together with capecitabine and oxaliplatin in treating patients with advanced solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor cells.

Conditions

  • Adenocarcinoma of the Pancreas
  • Adenocarcinoma of the Stomach
  • BRCA1 Mutation Carrier
  • BRCA2 Mutation Carrier
  • Ovarian Mucinous Cystadenocarcinoma
  • Recurrent Breast Cancer
  • Recurrent Colon Cancer
  • Recurrent Gastric Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pancreatic Cancer
  • Recurrent Rectal Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Colon Cancer
  • Stage IV Gastric Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Pancreatic Cancer
  • Stage IV Rectal Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

veliparib

Given PO

DRUG

capecitabine

Given PO

DRUG

oxaliplatin

Given IV

OTHER

pharmacological study

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William Schelman · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233505 on ClinicalTrials.gov