Completed

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

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What is being tested

Data Collection

Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00084786
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
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)



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center
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