Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments erlotinib, capecitabine, radiation therapy, gemcitabine
Phase phase 2
Target EGFR
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator Genentech
Start date April 2009
End date April 2014
Trial size 40 participants
Trial identifier NCT00962520, J-0534B, NA_00025965

Summary

This study is a phase II trial of erlotinib in combination with chemoradiation in patients with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 by mouth twice daily (PO BID) (5 days on/2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This study is a phase II trial of erlotinib in combination with chemoradiation in patients with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
erlotinib Tarceva
Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)
capecitabine Xeloda
Capecitabine 800 mg/m2 PO BID (1600 mg/m2 total) (5 days on/2 days off regimen)
radiation therapy
Radiotherapy 50.4 Gy delivered over 28 fractions (Mon-Fri)
gemcitabine Gemzar
Gemcitabine 1000 mg/m2 D1,8, and 15 every 28 days x 4 cycles
erlotinib Tarceva
Erlotinib 100 mg PO QD x 4 months

Primary Outcomes

Measure
Progression free survival
time frame: 5 years

Secondary Outcomes

Measure
Characterize toxicity profile for Tarceva based chemoradiation
time frame: 5 years
Quality of Life Assessments
time frame: 5 years
Overall survival of Tarceva and standard adjuvant chemoradiation and chemotherapy
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Resection of a stage I/II pancreatic adenocarcinoma of the pancreas (R0/R1) and a candidate to receive postoperative adjuvant chemoradiation. R2 ( macroscopic resection) based on the surgeons operative note will be excluded from the study. 2. Aged 18 years or older. 3. ECOG performance status < 1. 4. The effects of Erlotinib and Capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5. Patients must have normal organ and marrow function as defined below: - leukocytes > or = 3,000/μl - absolute neutrophil count > or = 1,500/μl - platelets > or = 100,000/μl - total bilirubin < or = 2 mg/dL - AST(SGOT)/ALT(SGPT) < or = 5 X institutional upper limit of normal - creatinine < or = 2 mg/dL - aPTT < 40 seconds, - PT < 2 seconds more than ULN. 6. Provision of written informed consent 7. Patients must have a working knowledge of English in order to complete the quality of life questionnaires. Patients that do not meet this requirement will be exempt from the QoL assessment, but remain eligible for all other components of the study. Exclusion Criteria: 1. Known severe hypersensitivity to Erlotinib any of the excipient of this product. Hypersensitivity to Capecitabine, doxifluridine, or 5-FU. 2. Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, non-invasive early stage bladder cancer (< T1), and cervical cancer in situ. 3. Uncontrolled, intercurrent illness including (but not limited to) ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort. Careful monitoring of PT/INR must be done for patients taking Warfarin. 5. Incomplete healing from previous oncologic or other major surgery. 6. Gastrointestinal tract disease resulting in an inability to take oral medication. 7. Pregnant women are excluded from this study because Erlotinib is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Erlotinib, breastfeeding should be discontinued if the mother is treated with Erlotinib. Capecitabine is also potentially teratogenic and its metabolites can be found in breast milk. 8. Patients with known AIDS or who are HIV-positive on anti-retroviral therapy are excluded since patients' immune deficiency are at increased risk of lethal infection when treated with marrow-suppressive therapy, and interactions between Erlotinib and anti-retroviral therapy are unknown. If patients have known risk factors of HIV they should be tested based on the discretion of the treating oncologist. 9. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded). 10. Previous radiation to the abdomen. 11. Previous chemotherapy for pancreatic cancer.

Additional Information

Official title Phase II Study of Erlotinib (TarcevaTM) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.