search
Back to results

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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gefitinib
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
  • Veterans Affairs Medical Center - Baltimore

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
November 5, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00014183
Brief Title
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
Official Title
A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A. Dawson, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Veterans Affairs Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs