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

August 28, 2017 updated by: Institut Català d'Oncologia

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet, Barcelona, Spain, 08907
        • Institut Catala d'Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Drug: Gemcitabine
1000mg/m2 / / 40mg/m2
Other Names:
  • gemzar
Radiation: Radiotherapy
50.4 Gy
Drug: Tarceva
100mg/day
Other Names:
  • Erlotinib
Drug: Oxaliplatin
100mg/m2 (only in QT)
Other Names:
  • ELOXATIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
Time Frame: Two years
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.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median overall survival.
Time Frame: Two years
To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
Two years
Rate of resections with engative margins and complete pathological response.
Time Frame: Two years
To determine the rate of negative margin resections and complete pathological response (cPR).
Two years
Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9)
Time Frame: Two years
To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
Two years
Ratio of objective responses (RECIST).
Time Frame: Two years
To determine the ratio of objective responses according to RECIST criteria.
Two years
Prognosis accuracy of serum protein profiles
Time Frame: Two years
To determine the prognosis accuracy of serum protein profiles in these subjects.
Two years
Viability of the collection of pre-treatment tumor samples
Time Frame: Two years
To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment.
Two years
Adverse events
Time Frame: Two years
To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Català d'Oncologia

Investigators

  • Principal Investigator: Berta Laquente, MD, ICO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 10, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (ESTIMATE)

February 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-20431
  • 2010-021872-27 (EUDRACT_NUMBER)
  • GEMERLOXA (OTHER: ICO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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