- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565487
Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer
May 17, 2018 updated by: Milton S. Hershey Medical Center
Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally 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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
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
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single arm
This is a single arm dose escalation study with a cohort expansion.
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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(orally) in an open-label, unblinded manner to all patients enrolled in the study.
During the treatment period, patients will receive single agent Tarceva 100 mg/day.
Treatment of Capecitabine & Tarceva is continued daily until the completeness of the radiation or toxicity.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.
Time Frame: Two years
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Two years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To assess treatment efficacy and overall survival.
Time Frame: Two years
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Two years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yixing Jiang, M.D., Penn State College of Medicine
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
December 1, 2007
Primary Completion (Actual)
August 5, 2014
Study Completion (Actual)
August 5, 2014
Study Registration Dates
First Submitted
November 29, 2007
First Submitted That Met QC Criteria
November 29, 2007
First Posted (Estimate)
November 30, 2007
Study Record Updates
Last Update Posted (Actual)
May 21, 2018
Last Update Submitted That Met QC Criteria
May 17, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Capecitabine
Other Study ID Numbers
- PSU 25709
- OSI4058s
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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