Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+769 other locations

Overseen byRoss A Abrams

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

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

I had surgery for pancreatic cancer that aimed to remove the tumor completely.

My surgery was 21-70 days ago, and I haven't started chemotherapy yet or it was 21-77 days if I've had up to 3 months of chemo.

I am 18 years old or older.

+19 more

Exclusion Criteria

I have had surgery to remove all or part of my pancreas.

I have not had chemotherapy for my pancreatic cancer unless it was one of the specified drugs.

I've had radiation in the same area as my current cancer.

+10 more

Participant Groups

The trial is testing the effectiveness of chemotherapy drugs gemcitabine hydrochloride, capecitabine, and fluorouracil with or without erlotinib hydrochloride and/or radiation therapy in patients post-surgery for pancreatic cancer. It aims to determine which combination is more effective at preventing cancer from returning.

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm IV (chemotherapy, chemoradiotherapy)Experimental Treatment11 Interventions

Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

Group II: Arm III (chemotherapy)Experimental Treatment7 Interventions

Patients receive the same treatment as in arm I for 1 month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

Group III: Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)Experimental Treatment7 Interventions

Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline. (closed to accrual 4/2/14)

Group IV: Arm I (gemcitabine hydrochloride or combination chemotherapy)Active Control7 Interventions

Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.