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Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors

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: NCT00084786
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : January 17, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gefitinib with docetaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when given with docetaxel in treating patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Drug: gefitinib Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of gefitinib when administered with docetaxel in patients with advanced solid tumors.
  • Determine the safety and efficacy of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gefitinib.

Patients receive oral gefitinib once daily on days 1 and 2 and docetaxel IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 3-42 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation of ZD1839 (Iressa®) (Days 1 and 2) and Docetaxel (Day 3) Every 3 Weeks in Patients With an Advanced Solid Tumor
Study Start Date : March 2004
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced solid tumor
  • Failed standard treatment OR no standard treatment exists
  • Measurable or evaluable indicator lesions
  • No uncontrolled CNS metastases (i.e., any known CNS lesion that is progressive [e.g., ≥ 25% growth], symptomatic, and/or requires escalating doses of corticosteroids)



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.0 times ULN


  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 55 mL/min


  • No congestive heart failure
  • No recent myocardial infarction
  • No unstable angina
  • No uncontrolled hypertension


  • No clinically active interstitial lung disease

    • Chronic, stable, asymptomatic radiographic changes allowed


  • No corneal abnormality
  • No history of dry eye syndrome or ocular surface diseases


  • No known severe hypersensitivity to gefitinib or any of its excipients
  • No unstable systemic disease
  • No active infection
  • No other significant medical history or unstable medical condition
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sperm donation during and for 3 months after study participation


Biologic therapy

  • Not specified


  • At least 3 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens for metastatic cancer
  • No prior docetaxel

Endocrine therapy

  • See Disease Characteristics


  • At least 3 weeks since prior radiotherapy to a major bone marrow-containing area


  • Not specified


  • No prior gefitinib or erlotinib
  • No other prior epidermal growth factor receptor tyrosine kinase inhibitors
  • More than 30 days since prior non-approved or other investigational drugs
  • No concurrent administration of any of the following CYP3A4 inhibitors or inducers:

    • Ketoconazole
    • Itraconazole
    • Clarithromycin
    • Erythromycin
    • Grapefruit juice
    • Troleandomycin
    • Diltiazem
    • Verapamil
    • Rifampin
    • Phenytoin
    • Carbamazepine
    • Barbiturates
    • Hypericum perforatum (St. John's wort)
  • No concurrent warfarin
  • No concurrent drugs that cause significant sustained elevations of gastric pH (pH ≥ 5)

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): NCT00084786

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: David B. Solit, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00084786    
Other Study ID Numbers: 04-003
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors