Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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