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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 CenterNew York, New York  10021