Clinical trial NCT00048087 (phase 2, status: withdrawn)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: zd1839, docetaxel
SMILES: COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    slow accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed non-small cell lung cancer.

          -  Measurable, evaluable disease outside of a radiation port.

          -  ECOG performance status 0-2.

          -  Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3,
             a platelet count >= 100,000/mm3, a WBC >= 3,000/ mm3, and a hemoglobin level of >= 9
             g/dl.

          -  One prior chemotherapy regimen. This may include chemoradiation treatment.

          -  Disease progression or recurrence within 6 months of last dose of chemotherapy in
             first chemotherapy regimen.

          -  At least a 2-week recovery from prior therapy toxicity.

          -  Signed informed consent.

          -  Prior CNS involvement by tumor are eligible if previously treated and clinically
             stable for two weeks after completion of treatment.

        Exclusion Criteria:

          -  Prior Iressa or other EGFR inhibiting agents

          -  Prior docetaxel therapy

          -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with
             the exception of basal cell carcinoma or cervical cancer in situ.

          -  Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
             therapy.

          -  Incomplete healing from previous oncologic or other major surgery.

          -  Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort,
             anti-coagulants.

          -  Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than
             100,000x 109/liter (L).

          -  Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).

          -  In the opinion of the investigator, any evidence of severe or uncontrolled systemic
             disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal
             disease).

          -  A serum creatinine >= 1.5 mg/dl and calculated creatinine clearance <= 60 cc/minute.

          -  Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5
             times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in
             the presence of liver metastases.

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the patient to participate in the trial.

          -  Pregnancy or breast feeding

          -  The patient has uncontrolled seizure disorder, active neurological disease, or Grade
             >= 2 neuropathy

          -  The patient has received any investigational agent(s) within 30 days of study entry.

          -  The patient has signs and symptoms of keratoconjunctivitis sicca or incompletely
             treated eye infection.