Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum
Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination
Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease
No known CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 9 g/dL
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
Alkaline phosphatase ≤ 5 times ULN

Renal

Creatinine ≤ 1.5 times ULN

Cardiovascular

No New York Heart Association class III or IV congestive heart failure
No QTc > 450 msec for males or > 470 msec for females
No personal or family history of congenital long QT syndrome

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No pre-existing neuropathy grade 2 or greater
No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor
No infection requiring parenteral or oral anti-infective treatment
No altered mental status or psychiatric condition that would preclude giving informed consent
No other medical condition that would preclude study participation
No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen < 2 ng/mL

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent sargramostim (GM-CSF)
No concurrent routine prophylactic use of filgrastim (G-CSF)

Chemotherapy

See Disease Characteristics
At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

Not specified

Radiotherapy

At least 3 weeks since prior radiotherapy and recovered

Surgery

At least 3 weeks since prior surgery and recovered

Other

More than 3 weeks since prior investigational agents (therapeutic or diagnostic)
No other concurrent therapy for advanced or metastatic colorectal cancer
No other concurrent investigational drugs