Clinical trial NCT00265876 (phase 1/phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: azd0530, gemcitabine hydrochloride
SMILES: CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1, 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 pancreatic adenocarcinoma

               -  Unresectable disease

               -  Locally advanced or metastatic disease

          -  Clinically or radiologically documented disease

               -  Measurable or evaluable disease (phase I)

               -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
                  conventional techniques OR ≥ 10 mm by spiral CT scan (phase II)

                    -  Measurable lesion must be outside of previously irradiated field if it is
                       the sole site of disease unless there is documented disease progression

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  More than 12 weeks

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute granulocyte count ≥ 1,500/mm^3

        Hepatic

          -  Bilirubin normal

          -  AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if clearly attributable
             to liver metastasis)

        Renal

          -  Creatinine normal

        Cardiovascular

          -  No active cardiomyopathy

          -  No congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No uncontrolled hypertension

          -  No myocardial infarction within the past 12 months

        Pulmonary

          -  No pulmonary disease requiring oxygen supplementation

        Gastrointestinal

          -  Must not require IV hyperalimentation

          -  No uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn's disease or
             ulcerative colitis)

          -  No active peptic ulcer disease

          -  No postsurgical malabsorption characterized by uncontrolled diarrhea that results in
             weight loss and vitamin deficiency

          -  No other GI tract disease resulting in an inability to take oral medications

          -  Must be able to take oral medication without crushing, dissolving, or chewing tablets

          -  Pancreatic enzyme supplementation allowed provided the above conditions are met

        Immunologic

          -  No immune deficiency

          -  No active, uncontrolled, or serious infection

          -  No know hypersensitivity to study drugs or their components

          -  No known HIV positivity

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of psychiatric illness (e.g., uncontrolled psychotic disorders) or
             neurologic disorder that would preclude study compliance

          -  No other serious medical condition or illness that would preclude study participation

          -  No other malignancy within the past 5 years except curatively treated nonmelanomatous
             skin cancer or carcinoma in situ of the cervix or bladder

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or
             gemcitabine given concurrently with radiotherapy as a radiosensitizer

               -  At least 4 weeks since prior fluorouracil or gemcitabine

        Endocrine therapy

          -  Concurrent systemic hormonal therapy for symptom control (e.g., appetite stimulation,
             pain, or nausea) allowed

        Radiotherapy

          -  See Disease Characteristics

          -  See Chemotherapy

          -  At least 4 weeks since prior radiotherapy for local disease and recovered

        Surgery

          -  At least 3 weeks since prior major surgery

        Other

          -  At least 2 weeks since prior anticancer therapy or investigational agents

          -  The following drugs must not be used for 1-2 weeks before, during, and for 1-2 weeks
             after completion of study treatment:

               -  Ketoconazole

               -  Itraconazole

               -  Ritonavir

               -  Mibefradil

               -  Clarithromycin

               -  Saquinavir mesylate

               -  Indinavir sulfate

               -  Erythromycin

               -  Nefazodone hydrochloride

               -  Fluconazole

               -  Diltiazem hydrochloride

               -  Alfentanil hydrochloride

               -  Carbamazepine

               -  Cyclosporine

               -  Tacrolimus

               -  Lovastatin

               -  Simvastatin

               -  Any other drug known to be a potent inhibitor of cytochrome 3A4

          -  No other concurrent anticancer therapy or investigational agents