Iressa/Docetaxel in Non-Small-Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: AstraZeneca; Aventis Pharmaceuticals
• Treatments: Docetaxel; Gefitinib

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.