Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Català d'Oncologia
• Treatments: Erlotinib Hydrochloride; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Before the beginning of the specific protocol procedures must be obtained and documented a written consent form. Patients must have sufficient capacity to understand and sign the consent form.

• Exocrine pancreatic potentially resectable carcinoma, histologically confirmed.

• Aged 18-75 years.

• OMS functional state (FE) from 0-2 and Karnofsky functional state 70%.

• Radiologically or measurable disease, defined as borderline resectability disease.

• Appropriate biological parameters: neutrophils > 1.500/mL; platelets > 100.000/mL; hemoglobin > 10 g/dl.Serum creatinine < 1,5 x upper limit of normal (LSN); alkaline phosphatase < 3 x LSN and bilirubin < 1,5 x LSN; AST and ALT 2,5 x LSN.

• Controlled biliary obstruction in all the patients before their inclusion in the study.

• Absence of peripheral neuropathy grade 2.

• Life expectancy of at least 3 months.

Exclusion Criteria:

• Previous administration of chemotherapy, radiotherapy or any investigational agents for pancreatic cancer treatment.

• Administration of other experimental treatment during this study or in the previous 6 months.

• Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are breast-feeding.

• Clinically significant heart disease(for example: congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not properly controlled with medication or myocardial infarction in the last 12 months).

• Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome, Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions that might increase the risk of epithelium complications.

• Patients with lack of physical integrity of the upper gastrointestinal tract or bad absorption syndromes or unable to ingest the tablets.

• Other previous bad or concurrent diseases, with the exception of nonmelanoma skin cancer.

• Medical or psychiatric pathologies that are severe or uncontrolled.

• Distant metastases.