Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01366144 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-205

 

This phase I trial studies the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastaticor cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 paclitaxel and carboplatin may kill more tumor cells

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Linda Pointon, 617-632-4391, linda_pointon@dfci.harvard.edu

Eligibility Criteria

DISEASE CHARACTERISTICS: - Patients must have histologically confirmed malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective, and for which there is expectation of response to the combination of carboplatin/paclitaxel (e.g., lung, ovarian, breast, or melanoma) - Hepatic OR renal dysfunction allowed - Patients with both hepatic and renal dysfunction are excluded - Patients with all degrees of renal dysfunction are allowed, including patients on hemodialysis - Patients with mild to severe hepatic dysfunction are allowed as defined below: - Total bilirubin ≤ 5 times upper limit of normal (ULN) AND AST and ALT ≤ 10 times ULN - Patients with a recently placed biliary stent should have consistent results within a hepatic group from two laboratory readings within 3 days apart, taken at least 10 days following biliary stent placement - For patients with a biliary stent placed over 2 months ago, no obstruction or blockage can have occurred within the last 2 months - Patients with brain metastasis should have stable disease for at least 4 weeks following therapy for brain metastasis, such as surgery, radiotherapy, or stereotactic radiosurgery PATIENT CHARACTERISTICS: - See Disease Characteristics - ECOG performance status (PS) 0-2 (Karnofsky PS > 60-100%) - Life expectancy of greater than 12 weeks - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 8.0 g/dL - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation - Not pregnant or nursing - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib (ABT-888) or other agents used in study - No peripheral neuropathy of severity greater than grade 1 - No inability to take oral medications on a continuous basis - No evidence of bleeding diathesis - No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - HIV-positive patients without an AIDS-defining diagnosis who are not receiving agents with the potential for pharmacokinetic interactions with ABT-888 may be eligible PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those whose adverse event due to agents administered more than 4 weeks earlier that have not resolved or stabilized - Patients who have been administered veliparib (ABT-888) as part of a single or combination phase 0 or I study should not necessarily be excluded from participating in this study solely because of receiving prior ABT-888 - No patients who received and progressed on the combination of carboplatin/paclitaxel - Patients may not be receiving any other investigational agents - HIV-positive patients on combination antiretroviral therapy are ineligible
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