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Iressa/Docetaxel in Non-Small-Cell Lung Cancer
This study has been terminated.
First Received: October 24, 2002   Last Updated: June 23, 2005   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborators: AstraZeneca
Aventis Pharmaceuticals
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00048087
  Purpose

Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by 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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

Estimated Enrollment: 50
Study Start Date: August 2002
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 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:

  • 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
No Contacts or Locations Provided
  More Information

No publications provided

Study ID Numbers: ID02-004
Study First Received: October 24, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00048087     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009