Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I clinical trial is studying the side effects and best dose of veliparib and gemcitabine hydrochloride when given with cisplatin in treating patients with advanced biliary, pancreatic, urothelial, or non-small cell lung 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 cisplatin and 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 more than one drug (combination chemotherapy) may kill more tumor cells. Veliparib may help cisplatin and gemcitabine hydrochloride work better by making tumor cells more sensitive to the drugs.

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

Details

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

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed advanced biliary/pancreatic cancer, urothelial cancer, or non-small cell lung cancer that is metastatic or unresectable

• Patients with known CNS metastases should be excluded from this clinical trial

• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)

• Life expectancy of greater than 12 weeks

• Absolute neutrophil count ≥ 1,500/mcL

• Platelets ≥ 100,000/mcL

• Total bilirubin within normal institutional limits

• AST/ALT ≤ 2.5 times institutional upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min

• QTc interval on ECG ≤ 0.48 seconds by Bazett's calculation (≤ CTCAE v.4 grade 2)

• Not pregnant or nursing

• 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

• Patients must be able to swallow pills and have no significant impairment in gastrointestinal absorption

• Patients with known or suspected germline mutation in BRCA1 or BRCA2 are eligible to participate

• Patients in study screening (primarily those with pancreatic cancer) who have a family history that is suspicious for BRCA1 or BRCA2 germline mutation should be assessed by the BRCAPRO computer program to quantitate the likelihood of harboring a deleterious BRCA mutation

• Patients found to have a BRCAPRO probability score of ≥ 20% should undergo formal full-sequence BRCA testing

• Patients in screening with a BRCAPRO probability of ≥ 20% who decline genetic testing are not eligible to participate in this trial due to the potential to confound safety assessment

• No uncontrolled intercurrent illness including, but not limited to:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness/social situations that would limit compliance with study requirements

• HIV-positive patients are eligible

• No active seizure or history of seizure disorder

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib (ABT-888) or other agents used in this study

• No peripheral neuropathy greater than grade1

• No prior systemic treatment

• No prior cytotoxic chemotherapy (neoadjuvant, adjuvant, or metastatic setting)

• At least 4 weeks since major surgery or radiation therapy

• Patients may not be receiving any other investigational agents