Clinical trial NCT00048087: Iressa/Docetaxel in Non-Small-Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Aventis Pharmaceuticals
First posted: 2002-10-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Patient Response Rate to Iressa/Docetaxel
timeFrame: 4 weeks cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Edward S. Kim, MD, BS
role: PRINCIPAL_INVESTIGATOR
References: