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Tyrosine Kinase Inhibitor

Chemotherapy for Pancreatic Cancer

Phase 3
Waitlist Available
Led By Ross A Abrams
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
Age >= 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 years
Awards & highlights

Study Summary

This trial is studying gemcitabine hydrochloride given with or without erlotinib hydrochloride, followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil, to see how well it works in treating patients with pancreatic cancer that has been removed by surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions, fatigue, digestive problems like nausea and diarrhea, skin rash (from erlotinib), low blood cell counts leading to increased infection risk or bleeding problems, liver function changes, and mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery for pancreatic cancer that aimed to remove the tumor completely.
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I am 18 years old or older.
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My liver enzyme SGOT levels are within the normal range.
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My surgery report confirms the entire tumor was removed and details on the edges and size of the tumor.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My CA19-9 levels are 180 units/mL or lower before starting any treatment.
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I can eat enough (>= 1500 calories/day) without feeling very nauseous or vomiting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (Phase II-R)
Overall survival (Phase III)
Secondary outcome measures
Changes in fatigue
Disease-free survival
Frequency of objective criteria of resectability as measured by preoperative imaging
+1 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Capecitabine
2013
Completed Phase 3
~3420
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Biospecimen Collection
2004
Completed Phase 2
~1720
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Chemotherapy
2003
Completed Phase 4
~3050
Computed Tomography
2017
Completed Phase 2
~2720
Erlotinib Hydrochloride
2010
Completed Phase 2
~2850
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
232 Previous Clinical Trials
100,231 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,708 Previous Clinical Trials
40,932,181 Total Patients Enrolled
Ross A AbramsPrincipal InvestigatorNRG Oncology

Media Library

Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01013649 — Phase 3
Pancreatic Neoplasm Research Study Groups: Arm I (gemcitabine hydrochloride or combination chemotherapy), Arm IV (chemotherapy, chemoradiotherapy), Arm II (gemcitabine hydrochloride, erlotinib hydrochloride), Arm III (chemotherapy)
Pancreatic Neoplasm Clinical Trial 2023: Erlotinib Hydrochloride Highlights & Side Effects. Trial Name: NCT01013649 — Phase 3
Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01013649 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the short- and long-term risks associated with Chemotherapy?

"Chemotherapy was given a safety rating of 3 by our analysts at Power. This is because Phase 3 trials have shown some efficacy and there is a wealth of safety data available."

Answered by AI

What are the most common purposes of Chemotherapy?

"Chemotherapy is most often used to treat actinic keratosis, but can also be useful in the treatment of colorectal carcinoma, malignant neoplasm of pancreas, and duke's c colon cancer."

Answered by AI

Has Chemotherapy been looked at in other research projects?

"There are currently 1064 clinical trials underway that are studying chemotherapy. Of those, 330 are in Phase 3. Although many of the trials for chemotherapy are based in Guangzhou, Guangdong, there are 49933 locations running studies for this treatment."

Answered by AI

Are there still open slots for new participants in this experiment?

"This particular study has completed recruitment for patients and is no longer enrolling. The study began on November 17th, 2009 and was last updated on September 23rd, 2022. For patients searching for other opportunities, there are 1,304 trials actively enrolling patients with pancreatic carcinoma and 1,064 studies for Chemotherapy actively enrolling patients."

Answered by AI
~36 spots leftby May 2025