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A Trial of ZD1839 (Iressa) in Patients With Advanced Renal Cell Carcinoma


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

Thank you

Trial Information

A Trial of ZD1839 (Iressa) in Patients With Advanced Renal Cell Carcinoma


OBJECTIVES: I. Determine the efficacy of ZD 1839 in patients with metastatic renal cell
cancer. II. Determine the time to disease progression in patients treated with this drug.
III. Determine the safety of this drug in these patients.

OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Patients are followed for at least
1 month.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma
Bidimensionally measurable disease Bone metastasis as only site must have at least 1
bidimensionally measurable tissue mass by CT or MRI (e.g., expansile lesion) Radiologic
evidence of disease progression or symptoms related to disease No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than
1.5 mg/dL ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine
no greater than 1.5 times ULN Other: No prior malignancy within the past 5 years unless
potentially curatively treated or deemed at low risk for recurrence Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No more than 1 prior biologic regimen No other concurrent biologic therapy
Chemotherapy: At least 4 weeks since prior cytotoxic therapy and recovered No more than 1
prior cytotoxic regimen No concurrent cytotoxic therapy Endocrine therapy: At least 4
weeks since prior hormonal therapy and recovered No more than 1 prior hormonal regimen No
concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068507

NCT ID:

NCT00012337

Start Date:

January 2001

Completion Date:

March 2004

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021