Expired Study
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Houston, Texas 77030


Purpose:

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.


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.


NCT ID:

NCT00048087


Primary Contact:

Principal Investigator
Edward S. Kim, MD, BS
UT MD Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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