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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 years
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 moreTrial 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
~2900
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
232 Previous Clinical Trials
100,230 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,952,815 Total Patients Enrolled
Ross A AbramsPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My surgical margins are unclear after consulting with my surgeon and pathologist.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.I have been cancer-free for 2 years, except for non-melanoma skin cancer or carcinoma in situ.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.Your bilirubin levels are not more than two times the normal limit.My creatinine levels are within the normal range for the last 3 weeks.My liver enzyme SGOT levels are within the normal range.I've had the required scans or x-rays for my abdomen, pelvis, and chest within the last 31 days.My surgery report confirms the entire tumor was removed and details on the edges and size of the tumor.I am fully active or restricted in physically strenuous activity but can do light work.You had a blood test within the last 21 days.I have HIV with a CD4 count over 499 and a viral load under 50, and I may be on HAART.You have enough white blood cells called neutrophils in your body.You need to have at least 100,000 platelets per cubic millimeter of blood.My CA19-9 levels are 180 units/mL or lower before starting any treatment.I had a severe heart attack in the last 3 months.I am currently on IV antibiotics for a bacterial or fungal infection.I do not have a severe lung condition that requires hospital care right now.A radiation oncologist has approved me for radiotherapy according to the protocol.My hemoglobin level is at least 8.0 g/dL.I can eat enough (>= 1500 calories/day) without feeling very nauseous or vomiting.I've had a full check-up, including weight and general health status, within the last month.I do not have any severe, active health problems.Women who could become pregnant must have a negative pregnancy test within 14 days before joining the study.My cancer is not one of the excluded types like neuroendocrine or IPMN with minor invasive parts.My cancer is in an early to mid-stage, without distant spread.I am not using, or willing to use, birth control and I could have children.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (gemcitabine hydrochloride or combination chemotherapy)
- Group 2: Arm IV (chemotherapy, chemoradiotherapy)
- Group 3: Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
- Group 4: Arm III (chemotherapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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