Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

June 9, 2010 updated by: Case Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
Time Frame: Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 9, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWRU3897
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CWRU-3897
  • NCI-G99-1530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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