ABT-888, Carboplatin, and Paclitaxel for Cancer With Liver or Kidney Problems

Withdrawn before enrolling · Phase 1

Conditions studied: Neoplasms

In brief

Background: \- Paclitaxel and carboplatin are two standard drugs that stop cancer cells from reproducing. ABT-888 is an experimental cancer drug that may prevent cancer cells from "fixing" the damage done by chemotherapy drugs. This may make the chemotherapy work better. More tests are needed to determine the safety and effectiveness of ABT-888 plus chemotherapy. Researchers also want to find the best dose of ABT-888 for people who have kidney or liver problems in addition to cancer. Objectives: \- To test the safety and effectiveness of ABT-888 plus carboplatin and paclitaxel in people who have both cancer and kidney or liver problems. Eligibility: * Individuals at least 18 years of age who have solid tumors that have not responded to standard treatment, and who also have kidney or liver problems. * A small group of people with solid tumors and normal kidney and liver function may also receive treatment for study comparison purposes. Design: * Participants will be screened with a medical history and physical exam. They will have blood and urine tests, tumor samples, tests of liver and kidney function, and imaging studies. Participants will also provide a hair sample at the start of the study. * Participants will take one dose of ABT-888 1 week before starting chemotherapy. The two chemotherapy drugs will be given on day 3 of a 21-day cycle. Participants will take ABT-888 daily for the first 7 days of each cycle. * They will keep a diary to record medication doses and any side effects. They will also have frequent blood tests and imaging studies. Participants will provide more hair samples on day 3 of cycle 1 before and after having paclitaxel. * Participants will continue treatment for up to 18 weeks as long as the cancer stops growing or shrinks and there are no serious side effects. Participants may have the option to continue treatment after the study is done.

Key facts

Study ID

NCT01419548

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2011-07-29

Expected to finish

2011-11-18

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 have not resolved or stabilized. Patients who have been administered 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.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in study.
• Peripheral neuropathy of severity greater than grade 1.
• Inability to take oral medications on a continuous basis.
• Evidence of bleeding diathesis.
• 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).
• 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.
• Pregnant women are excluded from this study because ABT-888 is PARP inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ABT-888, breastfeeding should be discontinued if the mother is treated with ABT-888. These potential risks may also apply to other agents used in this study.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with ABT-888 as well as possible interactions with paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. However, HIV-positive patients without an AIDS-defining diagnosis who are not receiving agents with the potential for PK interactions with ABT-888 may be eligible.
• Patients with both hepatic and renal dysfunction will also be excluded.
• Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• University of Pittsburgh Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.