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Chemotherapy in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Study NCT00024388   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: July 23, 2008   History of Changes

September 13, 2001
July 23, 2008
April 2001
 
 
 
Complete list of historical versions of study NCT00024388 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion In Patients With Metastatic, Locally Advanced, or Unresectable Renal Cell Carcinoma

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

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.

OBJECTIVES: I. Determine the tumor response rate, duration of response, and time to disease progression in patients with locally advanced, metastatic, or unresectable renal cell cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at completion of treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Phase II
Interventional
Treatment
Kidney Cancer
Drug: DHA-paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell cancer Locally advanced OR Metastatic OR Unresectable Measurable disease No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Cancer curatively treated with surgery alone that has not recurred for more than 5 years No concurrent serious infection requiring parenteral therapy No unstable or serious concurrent medical conditions No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for advanced disease No prior taxanes At least 28 days since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 28 days since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy No concurrent radiotherapy Surgery: At least 14 days since prior major surgery Other: Concurrent bisphosphonates allowed if on stable dose for at least 30 days prior to study No other concurrent anticancer therapy

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00024388
 
CDR0000068928, THERADEX-P01-00-07, CCF-IRB-4046, PROTARGA-P01-00-07
Theradex
 
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic
National Cancer Institute (NCI)
June 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP