Chemotherapy for Pancreatic Cancer

No longer recruiting at 796 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of different treatments for surgically removed pancreatic cancer. It compares chemotherapy alone to chemotherapy combined with erlotinib (a drug that blocks cancer cell growth) and/or radiation therapy. The goal is to determine which combination best prevents cancer from returning. Suitable participants have recently undergone pancreatic cancer surgery and have not received certain types of chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that gemcitabine hydrochloride is generally safe for treating cancer, though it can cause some side effects. About 10% of patients stopped treatment due to these effects. Common side effects include nausea and tiredness, but these are often manageable.

Studies have found that erlotinib hydrochloride is usually well-tolerated. It can cause mild to moderate side effects like skin rash and diarrhea, but these are typically not severe enough to stop treatment.

Capecitabine is often used with other cancer drugs, and patients should be aware of a higher risk of infection, especially during chemotherapy.

Radiation therapy methods like 3-dimensional and intensity-modulated radiation therapy target tumor cells precisely, minimizing damage to nearby tissues. Research suggests these methods have low rates of serious side effects, with nausea and tiredness being the most common.

Overall, these treatments are well-researched and have been used in cancer care with a known safety profile. However, each person may react differently, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pancreatic cancer because they offer unique approaches compared to the standard chemotherapy options like gemcitabine alone. One noteworthy feature is the combination of gemcitabine with erlotinib hydrochloride, which targets cancer cells more specifically by inhibiting the epidermal growth factor receptor (EGFR), potentially enhancing the treatment's effectiveness. Another innovative aspect is the integration of radiotherapy with chemotherapy, which could improve outcomes by attacking cancer from multiple angles simultaneously. These treatments represent promising advancements in tackling a challenging cancer type, showing potential for better targeting and possibly improved patient outcomes.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that gemcitabine hydrochloride, one of the treatments in this trial, effectively treats pancreatic cancer. Studies indicate that this treatment helps patients live longer and remain cancer-free for extended periods. In this trial, some participants will receive a combination of gemcitabine hydrochloride and erlotinib hydrochloride, which studies have shown to be more effective, with evidence indicating longer periods without cancer progression. Another treatment option in this trial involves capecitabine combined with radiotherapy, which has proven safe and effective. These treatments help stop tumor growth and spread, offering hope for better outcomes in pancreatic cancer. ^{6 7 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.

Your bilirubin levels are not more than two times the normal limit.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3924761/

Accelerated Fraction Radiotherapy With Capecitabine as ... This phase II trial was designed to determine the safety of accelerated fraction radiotherapy (AFRT) with capecitabine in patients with BR pancreatic cancer.

2. ascopubs.org ascopubs.org/doi/10.1200/jco.2015.33.3_suppl.377

Intensity-modulated radiation therapy (IMRT) in patients ... After IMRT, 81 patients received maintenance CT. Results: Acute grade 3 GI and hematologic toxicity were seen in 4 (2.9%) and 33 (24.6%) patients, respectively.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958394710001305

A Comparison of Helical Intensity-Modulated Radiotherapy ... Both HIMRT and IMRT offer a statistically significant improvement over 3D-CRT in lowering dose to liver, stomach, and bowel. The results were similar for both ...

4. jgo.amegroups.org jgo.amegroups.org/article/view/58221/html

Outcomes of patients with borderline resectable and ... This study aimed to compare the odds of achieving surgical resection, time to progression (TTP), and overall survival (OS) of patients treated with 3WCRT with ...

5. pfmjournal.org pfmjournal.org/m/journal/view.php?number=170

Redefining the role of radiation therapy in pancreatic ... In this review, we discuss innovations in RT and future directions for its role in the management of PDAC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468599/

Radiotherapy for Locally Advanced Pancreatic Cancer in ... Modern RT techniques for LAPC show favorable survival outcomes and low toxicity rates, compared with historical data. Considering modern RT ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4754068/

Dosimetric and clinical toxicity comparison of critical organ ... A comprehensive dosimetric study of pancreatic cancer treatment using three-dimensional conformal radiation therapy (3D-crt), intensity-modulated radiation ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(14)00548-9/abstract

Comparison of toxicity after IMRT and 3D-conformal ... IMRT has been suggested to reduce treatment-related toxicity in pancreatic cancer. We attempted to identify all IMRT-studies indexed in PubMed/Medline, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2452109423000957

Predictors of Acute and Late Toxicity in Patients Receiving ... At 3 months after radiation therapy, the rates of grade 2 or greater toxicities for nausea, fatigue, and abdominal pain were 8.0%, 7.0%, and 3.3%, respectively.

10. tro.amegroups.org tro.amegroups.org/article/view/4442/html

Effectiveness and acute toxicity of intensity-modulated ... Our systematic review and meta-analysis suggests that IMRT may be superior to 3D-CRT in the treatment of pancreatic cancer and may be associated with ...