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Iressa/Docetaxel in Non-Small-Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048087
Recruitment Status : Withdrawn (Slow accrual.)
First Posted : October 25, 2002
Last Update Posted : July 31, 2012
Aventis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: ZD1839 Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : August 2002
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

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 Name: Taxotere

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048087

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Aventis Pharmaceuticals
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Principal Investigator: Edward S. Kim, MD, BS UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00048087    
Other Study ID Numbers: ID02-004
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Non-small cell lung cancer
Additional relevant MeSH terms:
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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