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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

Must not have

Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. maximum follow-up at time of the phase iii analysis was 12.8 years, measured from step 2 randomization.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My surgical margins are unclear after consulting with my surgeon and pathologist.

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I do not have a severe lung condition that requires hospital care right now.

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My cancer is not one of the excluded types like neuroendocrine or IPMN with minor invasive parts.

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I am not using, or willing to use, birth control and I could have children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. maximum follow-up at time of the phase iii analysis was 12.8 years, measured from step 2 randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. maximum follow-up at time of the phase iii analysis was 12.8 years, measured from step 2 randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. maximum follow-up at time of the phase iii analysis was 12.8 years, measured from step 2 randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (Percentage of Participants Alive) [Phase III]

Overall Survival (Percentage of Participants Alive) [Phase II]

Secondary study objectives

Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]

Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]

Number of Participants by Highest Grade Adverse Event Reported (Phase II)

+2 more

Other study objectives

Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm IV (chemotherapy, chemoradiotherapy)Experimental Treatment6 Interventions

Patients receive the same treatment as in arm I or arm II for one 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 Treatment2 Interventions

Patients receive the same treatment as in arm I or arm II for one 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 Treatment2 Interventions

\[Closed to accrual 2-28-2014.\] 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.

Group IV: Arm I (gemcitabine hydrochloride or combination chemotherapy)Active Control2 Interventions

Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] 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

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Erlotinib Hydrochloride

2010

Completed Phase 2

~2900