Clinical trial NCT00550836 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: erlotinib hydrochloride, gemcitabine hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or
             undifferentiated)

               -  Metastatic disease

          -  No islet cell, acinar cell, or cystadenocarcinomas

          -  No locally advanced disease

          -  No history or known presence of CNS metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)

          -  AST ≤ 2.5 times ULN

          -  Creatinine ≤ 2.0 times ULN

          -  Magnesium ≥ lower limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing to provide a stool specimen

          -  No malignancy diagnosed within the past 3 years except basal cell or squamous cell
             skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix

          -  No uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  No clinically significant cardiovascular disease (i.e., myocardial infarction,
             unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac
             arrhythmia) within the past year

          -  No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic
             active hepatitis B infection

          -  No liver dysfunction from cirrhosis or viral hepatitis

          -  No enteral hyperalimentation

          -  No grapefruit or grapefruit juice during the study

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy

          -  More than 4 weeks since prior and no elective or planned major surgery

          -  More than 2 weeks since prior minor and no elective or planned surgery

          -  No prior cytotoxic chemotherapy for metastatic disease

               -  Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for
                  locally advanced disease is allowed, provided it was administered > 6 months
                  prior to study entry

                    -  Adjuvant chemotherapy must not have contained an EGFR inhibitor

               -  Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance
                  therapy is allowed, provided more than 6 months have elapsed since the last day
                  of treatment

          -  No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule
             EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)

          -  No concurrent immunotherapy or radiotherapy

          -  No other concurrent chemotherapy

          -  No concurrent colony-stimulating factors during the first course of study therapy