Study on Gemcitabine and Cisplatin with or without Veliparib for Treating Advanced Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01585805
This clinical trial is exploring whether adding the drug veliparib to the standard chemotherapy treatment of gemcitabine and cisplatin can improve outcomes for patients with advanced pancreatic cancer. The study also examines the effects of veliparib alone in certain patients.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if adding veliparib to the chemotherapy drugs gemcitabine and cisplatin can better control pancreatic cancer that has spread locally or to other parts of the body. Veliparib may help stop tumor growth by blocking certain enzymes needed for cancer cells to grow. The study will compare the effectiveness of the combination treatment to the standard chemotherapy alone and also evaluate veliparib as a single treatment option.
Description
This study is divided into two parts. In Part I, researchers will first determine the best dose of veliparib to use with gemcitabine and cisplatin. Then, patients will be randomly assigned to receive either the combination of veliparib, gemcitabine, and cisplatin (Arm A) or just gemcitabine and cisplatin (Arm B). The goal is to see how well these treatments work in patients with specific genetic mutations (BRCA or PALB2) and advanced pancreatic cancer.
In Part II, patients who have already received treatment for their cancer will receive veliparib alone (Arm C) to see if it can help control the disease.
Throughout the study, patients will undergo regular scans and provide blood and tumor samples to monitor the treatment's effects. After completing the study treatment, patients will have follow-up visits to check their health and the cancer's status.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older with advanced pancreatic cancer that has a BRCA1, BRCA2, or PALB2 mutation.
- For Part I, patients must not have received prior treatment for advanced cancer, but previous adjuvant therapy is allowed if it was completed more than 6 months ago.
- For Part II, patients can have had up to two prior treatments for advanced cancer, excluding previous PARP inhibitors.
- Good overall health with a performance status score of 0-1 for Part I and 0-2 for Part II.
- Life expectancy of more than 3 months.
- Adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
Exclusion Criteria
- Recent chemotherapy or radiotherapy within 3 weeks before starting the study.
- Previous treatment with PARP inhibitors.
- Allergic reactions to similar drugs used in the study.
- Uncontrolled illnesses such as active infections, heart failure, or psychiatric conditions.
- Pregnant or breastfeeding women.
- Active infections like hepatitis B or C, or uncontrolled seizures.
- Uncontrolled cancer spread to the brain.
- Inability to swallow pills or capsules.
- History of certain blood disorders or previous bone marrow transplants.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Ingalls Memorial Hospital | 60426 | Harvey | Illinois |
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
| Mercy Hospital Saint Louis | 63141 | St Louis | Missouri |
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Commack | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.