Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Adv… (NCT00565487) | Clinical Trial Compass
CompletedPhase 1
Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer
United States15 participantsStarted 2007-12
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 r…
What they're measuring
1
To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.