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 Has Been Removed by Surgery

Conditions

• Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Intraductal Papillary-Mucinous Neoplasm
• Stage I Pancreatic Cancer AJCC v6 and v7
• Stage II Pancreatic Cancer AJCC v6 and v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo 3-dimensional conformal radiation therapy
• Biospecimen Collection — PROCEDURE
  Undergo blood and tissue sample collection
• Capecitabine — DRUG
  Given PO
• Chemotherapy — DRUG
  Given combination chemotherapy
• Computed Tomography — PROCEDURE
  Undergo CT
• Erlotinib Hydrochloride — DRUG
  Given PO
• Fluorouracil — DRUG
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo intensity-modulated radiation therapy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• X-Ray Imaging — PROCEDURE
  Undergo x-ray imaging

Study Details

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.

Key Dates

First listed

Nov 16, 2009

Start date

Apr 5, 2010

Status verified

Feb 2026

Primary completion

Dec 10, 2023

Completion

Sep 4, 2025

Study Design

Enrollment

546 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (gemcitabine hydrochloride or combination chemotherapy)
  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.
• Experimental: Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
  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)
• Experimental: Arm III (chemotherapy)
  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.
• Experimental: Arm IV (chemotherapy, chemoradiotherapy)
  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.

Primary Outcome Measure

Overall Survival (Percentage of Participants Alive) [Phase II] [ Time Frame: From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. ]

Locations (678)

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