Clinical trial · Interventional
Iressa/Docetaxel in Non-Small-Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Iressa + Docetaxel
- interventionNames
- Drug: ZD1839
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Patient Response Rate to Iressa/Docetaxel
- timeFrame
- 4 weeks cycles
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
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