ABT-888, Carboplatin, and Paclitaxel for Cancer With Liver or Kidney Problems
Status:
Withdrawn
Trial end date:
2011-11-18
Target enrollment:
Participant gender:
Summary
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.