Iressa/Docetaxel in Non-Small-Cell Lung Cancer

This study has been withdrawn prior to enrollment.
(Slow accrual.)
Sponsor:
Collaborators:
AstraZeneca
Aventis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00048087
First received: October 24, 2002
Last updated: July 27, 2012
Last verified: July 2012
  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 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048087

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00048087     History of Changes
Other Study ID Numbers: ID02-004
Study First Received: October 24, 2002
Last Updated: July 27, 2012
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014