Chemotherapy with or without Panitumumab for Pancreatic Cancer
This study is looking at whether adding panitumumab to standard chemotherapy helps patients with pancreatic cancer that cannot be removed by surgery (unresectable), has spread locally (locally advanced), or has spread to other parts of the body (metastatic). Panitumumab is a monoclonal antibody that may stop cancer cells from growing. You may be able to join if you have pancreatic cancer that has been confirmed by a biopsy and your tumor does not have certain changes in the KRAS or BRAF V600E genes. The study will compare how long patients live (overall survival) when receiving chemotherapy with panitumumab versus chemotherapy alone. This study plans to enroll 94 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 94 participants. It compares two treatment approaches for pancreatic cancer.
- What's involved
- You would undergo blood sample collection and CT scans. You would receive chemotherapy with fluorouracil, gemcitabine, or irinotecan, potentially with panitumumab.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be measured from the date of randomization to the date of death, assessed for up to 3 years.
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NCT06998940
Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations
Recruiting
PHASE3Ages 18+InterventionalTreatmentSWOG Cancer Research NetworkGovernment-funded
~94 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyFluorouracilGemcitabineIrinotecanIrinotecan Sucrosofate
At a glance
Recruiting sites
272 of 274 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From date of randomization to date of death due to any cause, assessed up to 3 years
Conditions
NCT06998940
Where you'd take part
This study runs at 274 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Alaska Breast Care and Surgery LLC
Anchorage, Alaskastudy coordinator listed
Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaskastudy coordinator listed
Recruiting
Alaska Women's Cancer Care
Anchorage, Alaskastudy coordinator listed
Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraskastudy coordinator listed
Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraskastudy coordinator listed
Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraskastudy coordinator listed
Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, Californiastudy coordinator listed
Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaskastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Rachael A Safyan · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network
Who to contact
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Eligibility criteria
Inclusion
Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas
Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification status
NOTE: Blood-based next generation sequencing (NGS) assays, such as circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsies, will not be accepted for meeting eligibility criteria
Participants must have documented unresectable and/or metastatic disease on CT or magnetic resonance imaging (MRI) imaging completed prior to randomization. Imaging must have been completed within 28 days prior to randomization for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis
NOTE: Participants who are not tested for these mutations are eligible if they have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status
Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 28 days before randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day).
NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment
Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy.
Prior neoadjuvant or adjuvant therapy with 5-FU or gemcitabine-based chemotherapy counts as a line of therapy if the participant's disease progressed to locally advanced or metastatic disease within 6 months of completing treatment
Participants with cancers harboring molecular alterations including microsatellite instability (MSI-high), elevated tumor mutational burden (TMB) (TMB ≥ 10 mut/Mb), and FGFR1-3, NRG1, and ROS fusions are allowed to have received an additional line of targeted therapy applicable to the respective molecular alterations at the treating investigators discretion.
Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1/2 or PALB2 mutations does not count as a line of therapy.
Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)
Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib)
Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization
Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label
Participant must be ≥ 18 years old at the time of randomization
Participants must have Zubrod performance status of 0-2
Participants must have a complete medical history and physical exam within 28 days prior to randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Absolute neutrophil count ≥ 1.0 x 10\^3/uL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Note: Use of growth factor support (e.g., Granulocyte Colony-Stimulating Factor \[G-CSF\] or romiplostim \[Nplate\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
Hemoglobin ≥ 8 g/dL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Note: Use of growth factor support (e.g., G-CSF or romiplostim \[Nplate\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
Platelets ≥ 75 x 10\^3/uL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Note: Use of growth factor support (e.g., G-CSF or romiplostim \[Nplate\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Aspartate aminotransferase (AST) ≤ 10 x upper limits of normal (ULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Participants must have a creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
Participants must be offered the opportunity to participate in specimen banking
Participants who can complete patient reported outcomes (FACT-G and PRO-CTCAE) questionnaires in English or Spanish must be offered the opportunity to participate in the quality-of-life studies
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
What this trial measures
- Overall survival (OS)From date of randomization to date of death due to any cause, assessed up to 3 years
Analysis of OS will be conducted in all eligible participants according to the intent-to-treat principle using a 1-sided stratified log rank test.