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

Stopped early · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01233505

Run by

National Cancer Institute (NCI)

People needed

16

Starts

2010-10-01

Last updated by the study team

2014-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed solid tumors that fulfill ≥ 1 of the following criteria:
• BRCA1/2 mutation and a BRCA-related malignancy
• Patients without a known BRCA mutation must have a probability of harboring a BRCA gene mutation as assessed by BRCAPRO computer program
• Patients with a probability of having genetic mutation ≥ 20% or a BRCA mutation based on a non-Myriad test, must have a formal BRCA testing by Myriad Genetic Laboratories
• Patients with known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
• Patients who refuse BRCA testing not allowed unless they have another acceptable histology
• First- or second-line metastatic colorectal cancer
• Any-line metastatic mucinous ovarian cancer
• Any line of other metastatic gastrointestinal malignancies in which oxaliplatin has shown some activity (i.e., gastric or pancreatic adenocarcinoma)
• Patients with uncontrolled CNS metastasis are not eligible; patients with CNS metastases who have had them treated and are stable for > 3 months will be eligible; patients must be off steroid treatment prior to study enrollment
• Measurable disease
• Patients with ovarian cancer who have a pre-treatment CA 125 level of at least twice the upper limit of normal allowed
• ECOG performance status (PS) 0-2 (Karnofsky 60-100%)
• Life expectancy > 3 months
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases)
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fertile patients must use adequate contraception (i.e., hormonal, barrier method of birth control, or abstinence)
• Not pregnant or nursing
• Negative pregnancy test
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in study
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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