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

Sponsors and Collaborators:	Penn State University Genentech
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00565487

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: Capecitabine, Tarceva	Phase I

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Capecitabine Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer

Further study details as provided by Penn State University:

Primary Outcome Measures:

To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess treatment efficacy and overall survival. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	27
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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(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.

Arms

Assigned Interventions

1: Experimental

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(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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Capectabine & 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565487

Contacts

Contact: Yixing Jiang, M.D.	717-531-7568	yjiang@hmc.psu.edu
Contact: Rebecca Miller, RN, OCN	717-531-1003	rmiller13@hmc.psu.edu

Locations

United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Becky Miller, RN 717-531-1003 rmiller13@hmc.psu.edu
Principal Investigator: Yixing Jiang, MD

Sponsors and Collaborators

Penn State University

Genentech

Investigators

Principal Investigator:

Yixing Jiang, M.D.

Penn State College of Medicine

More Information

Responsible Party:	Penn State College of Medicine ( Yixing Jiang, MD )
Study ID Numbers:	PSU 25709, OSI4058s
Study First Received:	November 29, 2007
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00565487
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

Radiotherapy
Non-operable pancreatic cancer
locally advanced pancreatic cancer

Study placed in the following topic categories:

Erlotinib
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms

Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009