Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00077259


Primary Contact:

Study Chair
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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