ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of giving ABT-888 together with gemcitabine hydrochloride in treating patients with advanced solid tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with gemcitabine hydrochloride may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Veliparib

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumors meeting 1 of the following criteria:

• Progressive disease following standard therapy

• Disease for which acceptable standard treatment options do not exist

• May have received 0-2 prior chemotherapeutic regimens (single-agent or combination chemotherapies)

• Willing to undergo BRCA mutation analysis

• Known BRCA mutations allowed

• All patients, at any dose level, without a known BRCA mutation undergo screening with the BRCAPRO program to assess the likelihood of having a BRCA mutation

• Patients with a BRCAPRO likelihood of gene mutation of ≥ 20% must undergo BRCA gene testing by the Myriad Genetic Laboratories in order to participate in the study

• Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance

• No CNS disease (e.g., brain metastases or glioma)

• No active seizure or history of seizure disorder

• ECOG performance status 0-2 (Karnofsky 60-100%)

• Life expectancy > 3 months

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin < 2.0 mg/dL

• AST and ALT < 3 times upper limit of normal

• Creatinine normal OR creatinine clearance > 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to swallow pills

• HIV-positive patients allowed provided that CD4 counts are < 500 and not on protease inhibitors

• No uncontrolled diarrhea

• No 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 limit compliance with study requirements

• No other concurrent anticancer therapies or agents

• More than 4 weeks since prior major surgery, radiotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered

• Prior gemcitabine hydrochloride or PARP inhibition therapy, including ABT-888, allowed

• No prior combination of gemcitabine hydrochloride and any PARP inhibitor

• Concurrent bisphosphonate IV allowed provided treatment was initiated before study therapy (for patients with bone metastases or hypercalcemia)

• Patients with prostate cancer must continue luteinizing-hormone releasing-hormone agonist therapy and discontinue antiandrogens (≥ 6 weeks since bicalutamide and ≥ 4 weeks since flutamide)

• No other concurrent investigational agents