Colorectal Cancer
Conditions
Keywords
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
Brief summary
RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer.
Detailed description
OBJECTIVES: Primary * Determine the antitumor activity of epothilone D as second-line treatment, in terms of objective response rate, in patients with advanced or metastatic refractory colorectal cancer. Secondary * Determine the safety of this drug in these patients. * Determine the response duration in patients responding to treatment with this drug. * Determine time to tumor progression and overall survival in patients treated with this drug. * Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-69 patients will be accrued for this study.
Interventions
DRUGepothilone D
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed