Clinical trial · Interventional
Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available