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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014183
• Other study ID #: CDR0000068512
• Secondary ID: MSGCC-0044NCI-16
• Status: Completed
• Phase: Phase 2
• Start date: January 2001
• Est. completion date: August 2005

Study information

• Verified date: November 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• gefitinib

Locations

Country	Name	City	State
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center

Country where clinical trial is conducted

United States,