Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084786

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2004

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Naiyer Rizvi, MD	Memorial Sloan-Kettering Cancer Center
Principal Investigator:	David B. Solit, MD	Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000365619, MSKCC-04003
Study First Received:	June 10, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00084786
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Docetaxel
Gefitinib

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009