Combination Study Of Capecitabine And Erlotinib Concurrent With Radiotherapy For Non-Operable Advanced Pancreatic Cancer

Study Overview

Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer

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.

Over the past several decades, 5-fluorouracil based chemoradiation has been the cornerstone for the treatment of locally advanced non-operable pancreatic cancer. However, the survival of these patients is disappointing. The majority of the patients suffer either local progression or metastatic disease. With the availability of Capecitabine, a few pilot studies showed the the drug is convenient, tolerable and safe in combination with radiation therapy. Capecitabine demonstrated its superior anti-tumor activity with 14 months of median survival. However, these are small Phase I studies and the survival benefit needs to be further validated with larger studies. Epidermal growth factor receptor (EGFR) has been implicated in tumor growth and angiogenesis. Inhibiting EGFR by Tarceva has demonstrated effective treatment in metastatic pancreatic cancer. Anti-epidermal growth factor therapy in combination with radiotherapy has been demonstrated efficacious in other solid tumors such as head and neck cancer. We hypothesize that the combination of Tarceva and Capecitabine has synergistic anti-tumor effect. Hence, improvement of median survival could be potentially achieved with this novel combination.

Pancreatic Cancer

DRUG: Capecitabine, Tarceva

PSU 25709
OSI4058s

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-11-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-05-17
First Submitted that Met QC Criteria 2007-11-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-05-21
First Posted (ACTUAL) 2007-11-30	Results First Posted N/A	Last Verified 2018-05

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single arm This is a single arm dose escalation study with a cohort expansion.	DRUG: Capecitabine, Tarceva Capecitabine is a self-administered (oral) medication & will be dose escalated and administered in four dose levels: Level I - 600 mg/m2 bid; Level II - 700 mg/m2 bid; Level III - 825 mg/m2 bid; Level IV - 925 mg/m2 bid. Tarceva will be self-administered(

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Single arm

This is a single arm dose escalation study with a cohort expansion.

DRUG: Capecitabine, Tarceva

Capecitabine is a self-administered (oral) medication & will be dose escalated and administered in four dose levels: Level I - 600 mg/m2 bid; Level II - 700 mg/m2 bid; Level III - 825 mg/m2 bid; Level IV - 925 mg/m2 bid. Tarceva will be self-administered(

Primary Outcome Measures	Measure Description	Time Frame
To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.		Two years

Secondary Outcome Measures	Measure Description	Time Frame
To assess treatment efficacy and overall survival.		Two years

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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 requiring anticoagulation who may be safely switched to LMWH are eligible.

Collaborators and Investigators

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

Genentech, Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Yixing Jiang, M.D., Penn State College of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record