Clinical trial · Interventional
Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic 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: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer.
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 |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals
- description
- The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method
Secondary outcomes (5)
- measure
- Toxicity
- timeFrame
- Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.
- measure
- Response rate (complete response and partial response)
- timeFrame
- After every 4th cycle; End of Treatment and Follow-up
- description
- The response rate will be determined by the RECIST criteria. After every 4th cycle; End of Treatment and Follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic cancer * Locally advanced or metastatic disease * No active CNS metastases * Patients with stable CNS disease, who have undergone radiotherapy within the past 4 weeks and who have been on a stable dose of corticosteroids for \> 3 weeks, are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) (5 times ULN if known hepatic metastases) * AST and ALT ≤ 3 times ULN (5 times ULN if known hepatic metastases) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 90 days after completion of study treatment * No significant history of uncontrolled cardiac disease, including any of the following: * Uncontrolled hypertension * Unstable angina * Myocardial infarction within the past 6 months * Uncontrolled congestive heart failure * Cardiomyopathy with decreased ejection fraction * No prior severe infusion reaction to a monoclonal antibody * No active infection or fever ≥ 38.5°C within the past 3 days * No known hypersensitivity to any components of gemcitabine hydrochloride, oxaliplatin, or to a monoclonal antibody * No peripheral neuropathy ≥ grade 2 * No known HIV positivity * No hepatitis B or C infection (active, previously treated, or both) * No other medical condition, including mental illness or substance abuse, that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy, including surgery * More than 30 days since prior investigational therapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * More than 30 days since prior chemotherapy * No prior chemotherapy for metastatic pancreatic cancer * Prior fluoropyrimidine as a radiosensitizer allowed * Prior gemcitabine hydrochloride in the adjuvant setting allowed * No prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway * No prior allogeneic transplantation * No other concurrent investigational therapy, chemotherapy, or systemic antineoplastic therapy * No other concurrent treatment that targets the EGFR * No other concurrent monoclonal antibody therapy * No concurrent radiotherapy except for local control of bone pain
References
Publications (0)
Data not yet available