Iressa/Docetaxel in Non-Small-Cell Lung Cancer

M.D. Anderson Cancer Center

Status and phase

Withdrawn

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: ZD1839

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00048087

ID02-004

Details and patient eligibility

About

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.

Sex

All

Volunteers

No Healthy Volunteers

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.