Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop
perioperative complications due to the complexity of surgery. In these patients there is
also an increased risk of systemic relapse due to the advanced stage of the tumor as well as
a higher possibility of having positive margins. Therefore, the treatment of these patients
need to be decided based on a multidisciplinary strategy. Besides of that the use of
systemic neoadjuvant chemotherapy as induction therapy, followed by sequential
chemoradiotherapy is a very attractive therapeutic modality.
The neoadjuvant treatment offers the potential advantages of reducing the tumor stage,
increasing resectability and decreasing postoperative complications.
The administration of chemotherapy and radiotherapy before surgery represent an strategy for
early treatment of micrometastatic disease, present in most of these patients, and to
identify patients with rapid progression of the disease.
For all the reasons above, the investigators consider it's of great interest to design new
studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with
neoadjuvant intention in patients with pancreas cancer locally advanced.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
Outcome Description:
Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva.
Outcome Time Frame:
Two years
Safety Issue:
No
Principal Investigator
Berta Laquente, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
ICO
Authority:
Spain: Spanish Agency of Medicines
Study ID:
ICO-20431
NCT ID:
NCT01531712
Start Date:
July 2011
Completion Date:
December 2014
Related Keywords:
- Pancreatic Cancer
- neoadjuvant treatment
- borderline resectability
- Pancreatic Neoplasms
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