Comparing Two Treatment Combinations for Older Patients with Metastatic Pancreatic Cancer
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT04233866
This study is comparing two different chemotherapy combinations to see which one is more effective in extending the lives of older patients with pancreatic cancer that has spread to other parts of the body.
Patient Parameters
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Program Overview
This clinical trial is testing two different combinations of chemotherapy drugs to find out which one works better for older patients with pancreatic cancer that has spread. The drugs being tested are gemcitabine with nab-paclitaxel, and fluorouracil with leucovorin and liposomal irinotecan. These drugs work by stopping cancer cells from growing and spreading. The study aims to determine which combination helps patients live longer.
Description
The main goal of this study is to see which treatment combination helps patients live longer. Researchers will also look at how long patients live without the cancer getting worse and how well the tumors respond to the treatments.
The study will also assess the quality of life and daily functioning of patients, as well as any side effects they experience. This includes looking at how well patients can perform daily activities and whether they experience side effects like fatigue or nerve damage.
Patients will be randomly assigned to one of two groups:
- Group A: Patients will receive gemcitabine and nab-paclitaxel through an IV every two weeks.
- Group B: Patients will receive fluorouracil, leucovorin, and liposomal irinotecan through an IV every two weeks.
After finishing the treatment, patients will have follow-up visits every three months for two years to monitor their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Have newly diagnosed pancreatic cancer that has spread and has not been treated yet. Previous surgery or treatment is allowed if it was completed at least two weeks before joining the study.
- Be able to perform daily activities with little to no assistance (ECOG performance status 0-2).
- Be able to understand and complete the consent form and questionnaires in English.
- Have certain blood cell counts and organ function levels within normal ranges.
- If HIV positive, be on effective treatment with an undetectable viral load.
- If you have hepatitis B or C, the infection must be under control or cured.
- Male patients must agree not to father children during the study.
- Have measurable cancer that can be tracked with scans.
- Be classified as "vulnerable" based on a geriatric assessment, meaning mild to moderate health issues but not severe.
- Agree not to take certain medications that could interfere with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Thomas Hospital | 36532 | Fairhope | Alabama |
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| 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 |
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