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Chemotherapy in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DHA-paclitaxel
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology Associates
  • Jonsson Comprehensive Cancer Center, UCLA
  • Lucille Parker Markey Cancer Center, University of Kentucky
  • Louisiana State University Health Sciences Center - Shreveport
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Herbert Irving Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
July 23, 2008
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00024388
Brief Title
Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DHA-paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M. Bukowski, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-2254
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Lucille Parker Markey Cancer Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Chemotherapy in Treating Patients With Metastatic Kidney Cancer

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