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Iressa/Docetaxel in Non-Small-Cell Lung Cancer

This study has been withdrawn prior to enrollment.
(Slow accrual.)
Aventis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: October 24, 2002
Last updated: July 27, 2012
Last verified: July 2012
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: ZD1839 Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Response Rate to Iressa/Docetaxel [ Time Frame: 4 weeks cycles ]

Enrollment: 0
Study Start Date: August 2002
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Taxotere


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00048087

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Aventis Pharmaceuticals
Principal Investigator: Edward S. Kim, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00048087     History of Changes
Other Study ID Numbers: ID02-004
Study First Received: October 24, 2002
Last Updated: July 27, 2012

Keywords provided by M.D. Anderson Cancer Center:
Non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on August 17, 2017