A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)

Fecha de inicio: 1 de octubre de 2003

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