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Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer

Phase 1
18 Years
80 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Yixing Jiang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine


United States: Food and Drug Administration

Study ID:

PSU 25709



Start Date:

December 2007

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Radiotherapy
  • Non-operable pancreatic cancer
  • locally advanced pancreatic cancer
  • Pancreatic Neoplasms



Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033