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

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