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

This study has been completed.
Sponsor:
Collaborators:
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00014183
First received: April 10, 2001
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Kidney Cancer
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Study Start Date: January 2001
Study Completion Date: August 2005
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014183

Locations
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
University of Maryland Greenebaum Cancer Center
Investigators
Study Chair: Nancy A. Dawson, MD University of Maryland Greenebaum Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UM Greenebaum Cancer Center
ClinicalTrials.gov Identifier: NCT00014183     History of Changes
Other Study ID Numbers: CDR0000068512, MSGCC-0044, NCI-1639
Study First Received: April 10, 2001
Last Updated: September 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014