Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, recurrent rectal cancer, stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center