Study on Chemotherapy With or Without Panitumumab for Advanced Pancreatic Cancer Without KRAS Mutations
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT06998940
This clinical trial is exploring whether adding the drug panitumumab to standard chemotherapy can improve treatment outcomes for patients with advanced pancreatic cancer that does not have KRAS mutations.
Patient Parameters
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Program Overview
This study is testing if adding panitumumab, a type of protein that targets cancer cells, to standard chemotherapy can help treat pancreatic cancer that cannot be removed by surgery or has spread. The chemotherapy includes drugs like irinotecan, leucovorin, 5-FU, nab-paclitaxel, and gemcitabine, which work to stop cancer cells from growing and spreading. The trial aims to see if this combination is more effective than chemotherapy alone for patients with a specific type of pancreatic cancer that does not have KRAS mutations.
Description
The main goal of this study is to compare the overall survival of patients with advanced pancreatic cancer who receive panitumumab plus chemotherapy versus those who receive chemotherapy alone. Researchers will also look at how long patients live without the cancer getting worse, the response rate to the treatment, and the side effects experienced by patients.
Additional goals include examining the quality of life of patients during treatment and collecting samples for future research. Participants will be randomly assigned to one of two groups: one group will receive panitumumab with chemotherapy, and the other will receive chemotherapy alone. Both groups will undergo regular CT scans and blood tests to monitor their progress.
After completing the study treatment, patients will be followed up for up to three years to track their health outcomes.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of pancreatic ductal adenocarcinoma.
- Cancer must not have KRAS or BRAF V600E mutations, confirmed by specific lab tests.
- Cancer must be advanced, meaning it cannot be removed by surgery or has spread.
- Must not have certain other genetic mutations or amplifications.
- No known brain metastases unless treated and stable.
- Must have received only one prior chemotherapy treatment for advanced cancer.
- Must not have received certain prior treatments like anti-EGFR antibodies.
- Must be 18 years or older.
- Must have a good performance status, meaning able to carry out daily activities.
- Must have adequate blood counts and organ function.
- Must not have other serious health conditions that could interfere with the study.
- Must not be pregnant or breastfeeding and must agree to use effective contraception.
- Must be willing to participate in specimen banking and quality-of-life studies.
- Must provide informed consent to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | 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 |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Highlands Oncology Group - Fayetteville | 72703 | Fayetteville | Arkansas |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
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