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Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003928
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Kidney Cancer   

Drug Information available for:   Cisplatin    Gemcitabine hydrochloride    Gemcitabine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   38
Study Start Date:   January 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003928

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University    
      Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators
Ireland Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Scot C. Remick, MD     Case Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067117, CWRU-3897, NCI-G99-1530
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003928
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer  
recurrent renal cell cancer  

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Cisplatin
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Gemcitabine
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2008




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