Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer
Brief summary
Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may continue on daily Iressa until progressive disease and/or unacceptable toxicity.
Interventions
DRUGZD1839
250 mg by mouth daily each day for 4 weeks.
DRUGDocetaxel
30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
Sponsors
AstraZeneca
Aventis Pharmaceuticals
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Response Rate to Iressa/Docetaxel | 4 weeks cycles |
Countries
United States
Outcome results
None listed