Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003928
First received: November 1, 1999
Last updated: June 9, 2010
Last verified: June 2010
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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 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | January 1999 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: cisplatin
Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: 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.
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 Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Scot C. Remick, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003928 History of Changes |
| Other Study ID Numbers: | CWRU3897, P30CA043703, CWRU-3897, NCI-G99-1530 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Gemcitabine Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013