ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT00014183

Collaborator

National Cancer Institute (NCI) (NIH), University of Maryland Greenebaum Cancer Center (Other)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: gefitinib	Phase 2

Detailed Description

OBJECTIVES:

Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839.
Determine the median time to objective progression in these patients receiving this drug.
Determine the toxic effects of this drug in this patient population.
Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23 months.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

May 1, 2002

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery
Evidence of disease progression
Measurable disease
At least 20 mm with conventional techniques OR
At least 10 mm with spiral CT scan
No brain metastases
Malignant tissue available

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy:

More than 2 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal:

Creatinine no greater than 1.5 times ULN

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other:

No prior allergy to compounds of similar chemical or biologic composition to ZD 1839
No ongoing or active infection
No other uncontrolled illness or psychiatric condition that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens
At least 4 weeks since prior immunotherapy and recovered
No concurrent immunotherapy

Chemotherapy:

No more than 1 prior chemotherapy regimen
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No concurrent chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery:

See Disease Characteristics

Other:

No prior therapy for metastatic disease
No other concurrent investigational agents
No concurrent oral retinoids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
2	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland	United States	21201