Know Cancer

or
forgot password

A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma


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

Thank you

Trial Information

A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma


OBJECTIVES:

- Assess the response rate of patients with metastatic renal cell carcinoma treated with
gemcitabine and cisplatin.

- Assess toxicity of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin
IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 4 months.

PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven metastatic renal cell carcinoma

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,500/mm^3

- Hematocrit at least 30%

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- AST and ALT no greater than 1.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No uncontrolled hypertension

- No myocardial infarction within the past 8 weeks

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy within the past 5 years except nonmelanomatous skin cancer,
carcinoma in situ of cervix, prostate intraepithelial neoplasia, or superficial
bladder cancer

- No significant psychiatric disease

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than 2 prior biologic response modifier regimens

- No concurrent biologic therapy

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy allowed if measurable disease is outside radiation port

- At least 28 days since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- Prior surgery allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.

Outcome Time Frame:

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU3897

NCT ID:

NCT00003928

Start Date:

January 1999

Completion Date:

April 2006

Related Keywords:

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

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065