ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: erlotinib hydrochloride
Intervention description: Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer

Summary:

      To seek preliminary evidence of antitumor activity (progression free survival) of Erlotinib
      in combination with standard adjuvant chemoradiation and chemotherapy in patients with
      resected adenocarcinoma of the pancreas.
    

Eligibility criteria:

        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 (laparoscopic
             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.

          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.