Clinical trial · Interventional
PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca
A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Gemcitabine and cetuximab may make tumor cells more sensitive to radiation therapy. Giving gemcitabine together with cetuximab and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with cetuximab and radiation therapy in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention
- interventionNames
- Biological: cetuximab
- Drug: gemcitabine hydrochloride
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- Weekly and 4 weeks after last dose of radiation
Secondary outcomes (3)
- measure
- Dose-limiting toxicity
- timeFrame
- Weekly and 4 weeks after last dose of radiation
- measure
- Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or periampullary region, meeting both of the following criteria: * Unresectable disease * Locally advanced disease * Measurable or evaluable disease by CT scan or MRI * No evidence of metastatic disease outside of the planned irradiation field * ECOG performance status 0-2 * WBC ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.5 g/dL * AST and ALT ≤ 5 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL * Creatinine ≤ 2.0 mg/dL * No clinical indication of compromised function of nonirradiated kidney * No secondary malignancies within the past 5 years except for resected nonmelanoma skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception Exclusion Criteria: * No acute hepatitis * No known HIV infection * No other active or uncontrolled infection * No significant history of uncontrolled cardiac disease, including any of the following: * Hypertension * Unstable angina * Myocardial infarction within the past 6 months * Congestive heart failure * Cardiomyopathy with decreased ejection fraction * No prior severe infusion reaction to a monoclonal antibody PRIOR CONCURRENT THERAPY: * No prior radiotherapy to planned field of treatment * No prior therapy that specifically and directly targets EGFR pathway * At least 14 days since prior surgery or biopsy * At least 28 days since prior bypass procedures * More than 5 years since prior and no other concurrent chemotherapy * No other concurrent investigational agent
References
Publications (0)
Data not yet available