Chemotherapy for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have already started chemotherapy for pancreatic cancer, you must not have received certain types of chemotherapy agents other than those specified in the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of this treatment for pancreatic cancer?
Research shows that combining gemcitabine with erlotinib, a drug that targets specific cancer cell receptors, can slightly improve survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. Additionally, adding capecitabine to gemcitabine also shows modest improvements in survival.12345
Is the combination of gemcitabine and erlotinib safe for treating pancreatic cancer?
What makes the drug combination of erlotinib and gemcitabine unique for treating pancreatic cancer?
What is the purpose of this trial?
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.
Research Team
Ross A Abrams
Principal Investigator
NRG Oncology
Eligibility Criteria
Adults who've had surgery to remove pancreatic cancer and are in good health with no severe illnesses or recent heart issues. They should not have received certain prior treatments for their cancer, be able to eat normally without significant nausea, and must use effective contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gemcitabine hydrochloride or combination chemotherapy for 5 months
Chemoradiation
Participants undergo radiotherapy 5 days per week for 5.5 weeks with concurrent capecitabine or fluorouracil
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 3-Dimensional Conformal Radiation Therapy
- Capecitabine
- Erlotinib Hydrochloride
- Gemcitabine Hydrochloride
- Intensity-Modulated Radiation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator