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

NCT00565487 | Completed Phase 1 DMC

• 2 other identifiers: PSU 25709OSI4058s
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Radiotherapy; Non-operable pancreatic cancer; locally advanced pancreatic cancer

Outcome Measures

Primary Outcomes (1)

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

  Two years

Secondary Outcomes (1)

• To assess treatment efficacy and overall survival.

  Two years

Study Arms (1)

Single arm

EXPERIMENTAL

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

Drug: Capecitabine, Tarceva

Interventions

Capecitabine, Tarceva DRUG

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.

Also known as: Capecatine, Xeloda, Tarceva, Erlotinib, OSI-774

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

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

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yixing Jiang, M.D.

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: December 1, 2007
• Primary Completion: August 5, 2014
• Study Completion: August 5, 2014
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)