Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cancer of the colon or
rectum Clinical evidence of metastatic disease Failed 1 prior chemotherapy regimen for
metastatic disease 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 1.5
times ULN 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 unstable or serious concurrent medical condition No concurrent
serious infection requiring parenteral therapy No other prior malignancy except:
Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Other
cancer curatively treated with surgery alone that has not recurred for more than 5 years
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: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics No more than 1 prior chemotherapy regimen for metastatic disease
No prior taxanes At least 28 days since prior chemotherapy and recovered No other
concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At
least 28 days since prior large-field radiotherapy and recovered No concurrent
radiotherapy Surgery: At least 14 days since prior major surgery and recovered