Iressa/Docetaxel in Non-Small-Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00048087
• Other study ID #: ID02-004
• Status: Withdrawn
• Phase: Phase 2
• First received: October 24, 2002
• Last updated: July 27, 2012
• Start date: August 2002
• Est. completion date: July 2003

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• ZD1839
250 mg by mouth daily each day for 4 weeks.
• Docetaxel
30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	AstraZeneca, Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Response Rate to Iressa/Docetaxel		4 weeks cycles	No

External Links

•   UT MD Anderson Cancer Center website