Clinical trial · Interventional
Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer
A Phase I/ II, Non-randomized, Feasibility/ Safety and Efficacy Study of the Combination of Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer
NCT01077986CI-TRIAL-00051389completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study the investigators want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with 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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- phase I part: assessment of the dose limiting toxicity
- timeFrame
- During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter
- measure
- phase II part: response rate
- timeFrame
- Assessments after every 3 cycles (9 weeks).
Secondary outcomes (4)
- measure
- Time to treatment failure
- timeFrame
- Every 3 months during the first 2 years, and every 6 months thereafter.
- measure
- Overall survival
- timeFrame
- Every 3 months during the first 2 years, and every 6 months thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed content obtained prior to treatment * Cytological or histological confirmed adenocarcinoma of the pancreas * Metastatic pancreatic cancer * Measurable lesion according to RECIST criteria * ECOG/ WHO performance 0-2 * Age \> 18 years * Life expectancy \> 3 months * Adequate renal function (creatinine \< 150 µmol/L) * Adequate liver function (bilirubin \< 1.5 times upper limit of normal, ALAT or ASAT \< 5.0 times upper limit of normal in case of liver metastases and \< 2.5 the upper limit of normal in absence of liver metastases * Adequate bone marrow function (WBC \> 3.0 x 10 9/L, platelets \> 100 x 10 9/L) * Mentally, physically, and geographically able to undergo treatment and follow up Exclusion Criteria: * Clinical or radiological evidence of CNS metastases * Pregnancy (positive serum pregnancy test) and lactation * Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator * Patients who have any severe and/or uncontrolled medical conditions * Previous treatment with an mTOR inhibitor
References
Publications (0)
Data not yet available
No reference posted for this study.