Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 5, 2003
Last updated: February 26, 2011
Last verified: February 2006

June 5, 2003
February 26, 2011
October 2004
November 2010   (final data collection date for primary outcome measure)
Progression status at 6 months [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00062062 on Archive Site
  • Confirmed response rate (complete or partial response) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Quality of life as assessed by the Lung Cancer Symptom scale [ Designated as safety issue: No ]
  • Social support measure as assessed by the Lubben Social Network scale [ Designated as safety issue: No ]
  • Epidermal growth factor receptor concentrations [ Designated as safety issue: No ]
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Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.



  • Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel.


  • Determine the response rate in patients treated with these regimens.
  • Determine the quality of life of patients treated with these regimens.
  • Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens.
  • Correlate the presence of social support for these patients with toxicity and efficacy of these regimens.
  • Determine whether social support for these patients differs according to gender.
  • Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients.


  • Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician.

  • Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.

Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: gefitinib
  • Drug: paclitaxel
Not Provided
Mc Kean H, Stella PJ, Hillman SL, Rowland KM, Cannon MW, Behrens RJ, Gross GG, Sborov MD, Friedman EL, Jatoi A. Exploring therapeutic decisions in elderly patients with non-small cell lung cancer: results and conclusions from North Central Cancer Treatment Group Study N0222. Cancer Invest. 2011 May;29(4):266-71. doi: 10.3109/07357907.2010.535061. Epub 2011 Feb 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2010   (final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Metastatic or unresectable disease
  • Measurable disease

    • At least 1 lesion at least 2.0 cm
    • Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy
  • No meningeal carcinomatosis
  • No untreated brain metastases

    • Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy
  • No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)



  • 65 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL


  • Bilirubin no greater than 2.0 mg/dL
  • No uncontrolled hepatic disease


  • Creatinine no greater than 2 times upper limit of normal
  • No uncontrolled renal disease


  • No uncontrolled cardiac disease


  • No clinically active interstitial lung disease

    • Asymptomatic, chronic stable radiographic changes allowed
  • No uncontrolled respiratory disease


  • Fertile patients must use effective contraception
  • Able and willing to complete questionnaires alone or with assistance
  • No known hypersensitivity to gefitinib or any of its excipients
  • No active infection within the past 2 weeks
  • No other prior malignancy within the past 5 years except basal cell skin cancer
  • No grade 2 or greater peripheral neuropathy (CTC v2.0)
  • No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)
  • No dysphagia or inability to swallow intact capsules
  • No significant medical condition that would preclude study treatment or follow-up
  • No severe or uncontrolled systemic disease


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior chemotherapy for metastatic NSCLC

Endocrine therapy

  • Concurrent steroids allowed provided the dose is not changed


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-containing skeleton
  • No concurrent radiotherapy (including palliative)


  • See Disease Characteristics
  • At least 3 weeks since prior major surgery
  • No surgery within 7 days after study participation


  • More than 30 days since prior non-FDA approved investigational drugs
  • No concurrent oral retinoids
  • No concurrent CYP3A4-inducing agents, including the following:

    • Carbamazepine
    • Oxcarbazepine
    • Modafinil
    • Ethosuximide
    • Griseofulvin
    • Nafcillin
    • Phenobarbital
    • Phenylbutazone
    • Phenytoin
    • Primidone
    • Rifampin
    • Hypericum perforatum (St. John's wort)
    • Barbiturates
    • Sulfinpyrazone
  • No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)
  • No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration
  • No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin
65 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
CDR0000304453, NCCTG-N0222
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: Anne Kanard, MD Mayo Clinic
National Cancer Institute (NCI)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP