Veliparib, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer
NCT ID: NCT00535119
Last Updated: 2015-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
107 participants
INTERVENTIONAL
2007-09-30
Brief Summary
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Detailed Description
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I. To determine the recommended dose for phase II studies of veliparib (ABT-888 ) that can be administered in combination with carboplatin and paclitaxel in patients with advanced solid malignancies. (Stratum I) II. To determine the recommended dose for phase II studies of veliparib that can be administered in combination with carboplatin and paclitaxel in patients with advanced solid malignancies that harbor a germline BRCA1/2 mutation. (Stratum II) (added 04/07/09)
SECONDARY OBJECTIVES:
I. To define the dose-limiting toxicity and other toxicities associated with the use of this combination.
II. To obtain preliminary evidence of antitumor activity in patients treated with this combination.
III. To evaluate the pharmacokinetic parameters of veliparib, carboplatin, and paclitaxel when administered as a combination.
IV. To conduct correlative science studies.
OUTLINE: This is a multicenter, dose-escalation study of veliparib. Patients are stratified according to BRCA status (no \[stratum I\] vs yes \[stratum II\]).
Patients receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 3 and veliparib orally (PO) 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 and biomarker studies.
After completion of study treatment, patients are followed up for 4 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (enzyme inhibitor therapy and chemotherapy)
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 3 and veliparib PO 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.
Carboplatin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Pharmacological Study
Correlative studies
Veliparib
Given PO
Interventions
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Carboplatin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Pharmacological Study
Correlative studies
Veliparib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Suresh Ramalingam
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Cancer Institute (UPCI)
Locations
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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
Countries
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Other Identifiers
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NCI-2009-00258
Identifier Type: REGISTRY
Identifier Source: secondary_id
PCI-07-015
Identifier Type: -
Identifier Source: secondary_id
CDR0000566233
Identifier Type: -
Identifier Source: secondary_id
UPCI # 07-015
Identifier Type: OTHER
Identifier Source: secondary_id
7967
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00258
Identifier Type: -
Identifier Source: org_study_id
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