Veliparib, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer

Completed · Phase 1

Conditions studied: Adult Solid Neoplasm, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Hereditary Breast and Ovarian Cancer Syndrome

In brief

This phase I trial is studying the side effects and best dose of veliparib when given together with carboplatin and paclitaxel in treating patients with advanced solid cancer. Veliparib 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 veliparib together with carboplatin and paclitaxel may help kill more tumor cells.

Key facts

Study ID

NCT00535119

Run by

National Cancer Institute (NCI)

People needed

107

Starts

2007-09-01

Last updated by the study team

2015-05-22

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed advanced solid malignancy
• Patients enrolled in stratum II of the study must have BRCA1/2 mutation (added 04/07/09)
• Patients with CNS metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for > 3 months and must be off steroid treatment prior to study enrollment
• ECOG performance status 0-2
• Life expectancy > 12 weeks
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 3 weeks since prior radiotherapy
• Prior veliparib allowed

You may not qualify if…

• Known history of allergic reactions to veliparib, carboplatin, or Cremophor-paclitaxel
• Uncontrolled intercurrent illness, including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness or social situations that would preclude compliance with study requirements
• Peripheral neuropathy > grade 1
• Inability to take oral medications on a continuous basis
• Active seizure or history of seizure disorder
• Evidence of bleeding diathesis
• Received > 3 prior chemotherapy regimens for advanced stage disease for patients enrolled in stratum I (there is no upper limit on the number of prior regimens for patients enrolled in stratum II) (added 04/07/09)
• Adjuvant chemotherapy administered ≥ 2 years prior to enrollment to the study does not count as a prior chemotherapy regimen
• Other concurrent investigational agents
• Concurrent combination antiretroviral therapy for HIV-positive patients

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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