Panitumumab + Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding panitumumab to standard chemotherapy can enhance treatment for pancreatic cancer that is KRAS wild type (a specific genetic profile) and either inoperable or metastatic. Panitumumab is a protein that may block tumor growth and spread. The trial seeks participants with this specific type of pancreatic cancer who have not responded to one chemotherapy treatment. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have received any pancreatic anticancer therapy within 14 days before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that panitumumab, a monoclonal antibody, is generally well-tolerated by patients. Studies have found that most side effects are manageable, with skin reactions being the most common. In one study, 95% of patients experienced skin issues, but only 5% had severe cases. Importantly, no allergic reactions specific to panitumumab were reported. The FDA has approved panitumumab for other cancers, such as colorectal cancer, indicating a strong understanding of its safety.
The chemotherapy drugs used with panitumumab can cause side effects like tiredness, nausea, and low blood counts, but these effects vary among individuals. Overall, the treatment is considered safe enough for testing in large groups, as demonstrated in this trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about panitumumab in combination with chemotherapy for pancreatic cancer because it targets the epidermal growth factor receptor (EGFR), which plays a critical role in cancer cell growth. This mechanism is different from standard treatments, such as gemcitabine or nab-paclitaxel, which do not target EGFR directly. By adding panitumumab to the mix, there's potential to more effectively inhibit tumor growth, giving hope for improved outcomes in a condition that is notoriously difficult to treat.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
This trial will compare the effectiveness of adding panitumumab to standard chemotherapy for treating pancreatic cancer. Research has shown that adding panitumumab to chemotherapy might benefit patients with a specific genetic type called KRAS wild type. In some studies, patients who received panitumumab with chemotherapy lived longer than those who did not. Specifically, one study found that patients lived an average of 8.3 months with panitumumab, compared to 4.2 months without it. This suggests that panitumumab could enhance the effectiveness of standard treatments for certain types of pancreatic cancer.15678
Who Is on the Research Team?
Rachael A Safyan
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic ductal adenocarcinoma that can't be removed by surgery or has spread, who have KRAS and BRAF wild type tumors confirmed by tissue testing. Participants must have had only one prior chemotherapy treatment for advanced disease and no untreated brain metastases.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard chemotherapy or panitumumab plus chemotherapy in cycles repeating every 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Panitumumab
Trial Overview
The study compares standard chemotherapy (using drugs like irinotecan, leucovorin, 5-FU, nab-paclitaxel, and gemcitabine) with or without the addition of panitumumab to see if adding this targeted therapy helps people with certain types of pancreatic cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.
Patients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
A Phase II Randomized Trial of Panitumumab, Erlotinib ... - PMC
The median overall survival was 4.2 months in Arm A and 8.3 months in Arm B (hazard ratio, 0.817; 95% confidence interval [CI], 0.530–1.260; p = .1792). The ...
Phase II Study of Panitumumab, Chemotherapy, and External ...
The study had 91% power to detect a 12-month OS rate of 60%, with a 9% significance level when the true 12-month OS rate was 40%. An observed 12 ...
NCT06998940 | Studying Chemotherapy With or Without ...
Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal ...
N064A (Alliance): Phase II Study of Panitumumab ... - PubMed
The combination of panitumumab, chemotherapy, and external beam radiation therapy was associated with very high rates of grades 3-4 ...
5.
valuebasedcancer.com
valuebasedcancer.com/issues/2013/february-2013-vol-4-no-2/in-first-line-metastatic-crc-outcomes-comparable-for-panitumumab-and-bevacizumabIn First-Line Metastatic CRC, Outcomes Comparable for ...
The overall response rates were 82% with panitumumab and 76% with bevacizumab, and the resection rates were 13% and 11%, respectively. The treatment exposure to ...
NCT00613730 | Adenocarcinoma of the Pancreas Treated ...
Histologically or cytologically confirmed pancreatic adenocarcinoma meeting one of the following criteria: Locally advanced unresectable disease, or metastatic ...
Randomized phase II trial of panitumumab (P), erlotinib (E), ...
Conclusions: This study involved an initial run-in design to define tolerable doses of dual EGFR inhibitors, PGE, in pancreatic cancer patients.
Efficacy of Upfront Panitumumab Plus Intensified Chemo ...
Panitumumab with FOLFIRINOX or mFOLFOX6 showed high ORR but failed to meet the primary endpoint in liver-limited, RAS/BRAF wild-type mCRC ...
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