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
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Naiyer Rizvi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
04-003
NCT ID:
NCT00084786
Start Date:
March 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
