Clinical trial · Interventional
Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer
Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer
NCT00565487CI-TRIAL-00033024completedPhase 1ClinicalTrials.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)
The primary purpose of this study is to determine the best dosage of Capecitabine and Tarceva combination in the setting of radiation and to assess treatment effectiveness, progression-free survival and overall survival.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Tarceva | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- This is a single arm dose escalation study with a cohort expansion.
- interventionNames
- Drug: Capecitabine, Tarceva
Primary outcomes (1)
- measure
- To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.
- timeFrame
- Two years
Secondary outcomes (1)
- measure
- To assess treatment efficacy and overall survival.
- timeFrame
- Two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of adenocarcinoma of the pancreas that is locally advanced \& not amenable to resection with curative intent. * Must not have received prior systemic therapy for locally advanced disease. * ECOG performance status must be 0-2. * Adequate hepatic, renal \& bone marrow function. * Radiographic evidence of disease is required. * Life expectancy \> 12 weeks. Exclusion Criteria: * Prior treatment with Capecitabine \& other EGFR inhibitor. * Patients with GI tract disease resulting in an inability to take oral medications. * Significant GI disorders with diarrhea as a major symptom. * Uncontrolled intercurrent illness including active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias now well controlled with medication, myocardial infarction within the previous 6 months, psychiatric illness/social situations that would limit compliance with study requirements. * Patients with metastases. * Patients who have had chemotherapy. * Patients may not be receiving any other investigational agents, or have participated in any investigational drug study. * Extensive symptomatic fibrosis of the lungs. * Females who are pregnant or lactating. * History of any other malignancy in the last 2 years, except prior history of in situ cancer, basal or squamous cell skin cancer are eligible. * Known DPD deficiency. * Receiving therapeutic doses of Coumarin-derivative anticoagulant therapy. Patients requiring anticoagulation who may be safely switched to LMWH are eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.