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

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.

Study Overview

• Status: Withdrawn
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: ZD1839; Drug: Docetaxel

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iressa + Docetaxel	Drug: ZD1839; 250 mg by mouth daily each day for 4 weeks.; Other Names: Iressa; Gefitinib; Drug: Docetaxel; 30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.; Other Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Response Rate to Iressa/Docetaxel	4 weeks cycles

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: AstraZeneca; Aventis Pharmaceuticals
• Investigators: Principal Investigator: Edward S. Kim, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

Helpful Links

• UT MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: October 24, 2002
• First Submitted That Met QC Criteria: October 24, 2002
• First Posted (Estimate): October 25, 2002

Study Record Updates

• Last Update Posted (Estimate): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 27, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Gefitinib
• Other Study ID Numbers: ID02-004