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Phase II Study of Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI, Pharmaceutical / Industry
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MSKCC-03113 ROCHE-NO17320, NCT00077259
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy - No concurrent sargramostim (GM-CSF)
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No concurrent routine prophylactic use of filgrastim (G-CSF)
Chemotherapy - See Disease Characteristics
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At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy 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)
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No other concurrent therapy for advanced or metastatic colorectal cancer
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No other concurrent investigational drugs
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Hemoglobin ≥ 9 g/dL
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Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN)
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AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
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Alkaline phosphatase ≤ 5 times ULN
Renal - Creatinine ≤ 1.5 times ULN
Cardiovascular - No New York Heart Association class III or IV congestive heart failure
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No QTc > 450 msec for males or > 470 msec for females
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No personal or family history of congenital long QT syndrome
Other - Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective barrier contraception
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No pre-existing neuropathy grade 2 or greater
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No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor
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No infection requiring parenteral or oral anti-infective treatment
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No altered mental status or psychiatric condition that would preclude giving informed consent
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No other medical condition that would preclude study participation
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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
Expected Enrollment A total of 19-69 patients will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Memorial Sloan-Kettering Cancer Center | | | Leonard Saltz, MD, Protocol chair | | Ph: 212-639-2501; 800-525-2225 |
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Registry Information | | Official Title | | 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)
| | Trial Start Date | | 2003-10-14 | | Registered in ClinicalTrials.gov | | NCT00077259 | | Date Submitted to PDQ | | 2003-12-16 | | Information Last Verified | | 2005-04-06 | | NCI Grant/Contract Number | | P30-CA08748 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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