Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

Thank you

Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald M. Bukowski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Lucille Parker Markey Cancer Center, University of Kentucky Lexington, Kentucky  40536-0093
Arizona Oncology Associates Tucson, Arizona  85712-2254