Status:
COMPLETED
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 epot...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00077259
Start Date
October 1 2003
Last Update
January 16 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021