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

NCT ID: NCT01531712

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-10
• Study Completion Date: 2012-12-31

Brief 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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QT + QRT

Chemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day.

Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy).

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1000mg/m2 / / 40mg/m2

Radiotherapy

Intervention Type: RADIATION

50.4 Gy

Tarceva

Intervention Type: DRUG

100mg/day

Oxaliplatin

Intervention Type: DRUG

100mg/m2 (only in QT)

Interventions

Gemcitabine

1000mg/m2 / / 40mg/m2

Intervention Type: DRUG

Radiotherapy

50.4 Gy

Intervention Type: RADIATION

Tarceva

100mg/day

Intervention Type: DRUG

Oxaliplatin

100mg/m2 (only in QT)

Intervention Type: DRUG

Other Intervention Names

gemzar; Erlotinib; ELOXATIN

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berta Laquente, MD

Role: PRINCIPAL_INVESTIGATOR

ICO

Locations

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Other Identifiers

2010-021872-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GEMERLOXA

Identifier Type: OTHER

Identifier Source: secondary_id

ICO-20431

Identifier Type: -

Identifier Source: org_study_id