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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nancy A. Dawson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068512

NCT ID:

NCT00014183

Start Date:

January 2001

Completion Date:

August 2005

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201