Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

NCT00003928 | Completed Phase 2 DMC

• 4 other identifiers: CWRU3897P30CA043703CWRU-3897NCI-G99-1530
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

cisplatin DRUG

Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

gemcitabine hydrochloride DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Scot C. Remick, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1999
• Primary Completion: February 1, 2005
• Study Completion: April 1, 2006
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)