Testing Pevonedistat with Chemotherapy for Liver Bile Duct Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04175912
This study is exploring how well the drug pevonedistat works alone or with chemotherapy drugs paclitaxel and carboplatin in treating liver bile duct cancer. The goal is to see if these treatments can shrink tumors and improve patient outcomes.
Patient Parameters
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Program Overview
This clinical trial is investigating whether pevonedistat, a drug that may stop cancer cells from growing, can effectively treat bile duct cancer in the liver. The study is testing pevonedistat both on its own and in combination with chemotherapy drugs paclitaxel and carboplatin, which work by killing cancer cells or stopping them from spreading. Researchers aim to find out how well these treatments can shrink tumors in patients with this type of cancer.
Description
The main goal of this study is to see how well pevonedistat, both alone and with chemotherapy drugs carboplatin and paclitaxel, can reduce tumors in patients with advanced bile duct cancer in the liver that cannot be removed by surgery.
Secondary goals include evaluating the safety of these treatments and determining how long patients live without the cancer getting worse and their overall survival. Researchers will also explore if certain genetic markers can predict how well patients respond to the treatment.
Participants will be randomly assigned to one of two groups. One group will receive pevonedistat alone, while the other group will receive pevonedistat along with paclitaxel and carboplatin. Treatments will be given in cycles every 21 days, as long as the cancer does not progress or side effects are manageable. After completing the study treatment, patients will have follow-up visits to monitor their health and the effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a good performance status, meaning able to carry out daily activities with minimal restrictions.
- Must have a life expectancy of at least 12 weeks.
- Must have a confirmed diagnosis of advanced bile duct cancer in the liver that cannot be surgically removed and has worsened after previous chemotherapy.
- Must have measurable cancer that can be tracked during the study.
- Must have adequate blood cell counts and organ function based on specific medical tests.
- HIV-positive patients can participate if their condition is well-controlled.
- Patients with hepatitis B or C can participate if their viral load is undetectable or they have been treated and cured.
- Must be able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Must not have had major surgery within 14 days before starting the study.
- Women must not be pregnant or breastfeeding, and both men and women must agree to use effective birth control during the study and for four months after.
- Must not have a prolonged QT interval on an ECG, which is a measure of heart rhythm.
- Must not have unresolved side effects from previous cancer treatments, except for hair loss.
- Must not have persistent diarrhea or known brain involvement by cancer.
- Must not be taking other investigational drugs or have received certain treatments recently.
- Must not have a history of allergic reactions to similar drugs used in the study.
- Must not have uncontrolled illnesses or infections.
- Must not have certain lung diseases or psychiatric conditions that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
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