Phase II Study of Erlotinib (TarcevaTM) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
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.
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
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
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.