A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Combination With Docetaxel in Patients With Recurrent or Metastatic Advanced Non-Small Cell Lung Cancer
- 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.
- 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
- Incomplete healing from previous oncologic or other major surgery.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's
- 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
- 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.