Chemotherapy for Pancreatic Cancer

Recruiting at 770 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Non-adenocarcinomas, Total pancreatectomy, Prior radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 5 months

546 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have already started chemotherapy for pancreatic cancer, you must not have received certain types of chemotherapy agents other than those specified in the trial. It's best to discuss your current medications with the trial team.

Is the combination of gemcitabine and erlotinib safe for treating pancreatic cancer?

The combination of gemcitabine and erlotinib is generally considered safe for treating pancreatic cancer, but it can cause side effects like diarrhea, rash, and skin issues. These side effects are common but usually manageable. ^{1 2 3 4 5}

What makes the drug combination of erlotinib and gemcitabine unique for treating pancreatic cancer?

The combination of erlotinib and gemcitabine is unique because it targets the epidermal growth factor receptor (EGFR), which is often overexpressed in pancreatic cancer, and has shown a small but significant increase in survival compared to gemcitabine alone, despite increased toxicity. ^{1 2 5 6 7}

What data supports the effectiveness of this treatment for pancreatic cancer?

Research shows that combining gemcitabine with erlotinib, a drug that targets specific cancer cell receptors, can slightly improve survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. Additionally, adding capecitabine to gemcitabine also shows modest improvements in survival. ^{1 6 8 9 10}

Who Is on the Research Team?

Ross A Abrams

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.

Women of childbearing potential and male participants must practice adequate contraception

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive gemcitabine hydrochloride or combination chemotherapy for 5 months

5 months

Weekly visits for chemotherapy administration

Chemoradiation

Participants undergo radiotherapy 5 days per week for 5.5 weeks with concurrent capecitabine or fluorouracil

5.5 weeks

Daily visits for radiotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years, then yearly

Every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• 3-Dimensional Conformal Radiation Therapy
• Capecitabine
• Erlotinib Hydrochloride
• Gemcitabine Hydrochloride
• Intensity-Modulated Radiation Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm IV (chemotherapy, chemoradiotherapy) Experimental Treatment 11 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 Treatment 7 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 Treatment 7 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 Control 7 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Published Research Related to This Trial

A combination of gemcitabine and erlotinib has been shown to provide a survival advantage in patients with locally advanced and metastatic pancreatic cancer compared to gemcitabine alone, highlighting its efficacy in a disease known for poor outcomes.

Erlotinib, a tyrosine kinase inhibitor targeting the epidermal growth factor receptor, demonstrates anti-tumor activity when used alongside gemcitabine, suggesting a promising mechanism of action in treating pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of erlotinib in the management of pancreatic cancer. Starling, N., Neoptolemos, J., Cunningham, D.[2021]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Role of erlotinib in the management of pancreatic cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Erlotinib: success of a molecularly targeted agent for the treatment of advanced pancreatic cancer. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A phase II study of erlotinib in gemcitabine refractory advanced pancreatic cancer. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Erlotinib-induced episcleritis in a patient with pancreatic cancer. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Frontline treatment with gemcitabine, oxaliplatin and erlotinib for the treatment of advanced or metastatic pancreatic cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG). [2022]