Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00084786
First received: June 10, 2004
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Drug: gefitinib
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: March 2004
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

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

Pulmonary

  • No clinically active interstitial lung disease

    • Chronic, stable, asymptomatic radiographic changes allowed

Ophthalmic

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • Not specified

Other

  • 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)
  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: NCT00084786

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Naiyer Rizvi, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: David B. Solit, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00084786     History of Changes
Other Study ID Numbers: 04-003, MSKCC-04003
Study First Received: June 10, 2004
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
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 20, 2014