Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003928
• Other study ID #: CWRU3897
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 9, 2010
• Start date: January 1999
• Est. completion date: April 2006

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2006
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• cisplatin
Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• gemcitabine hydrochloride
Gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.		Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	No