NCT00022477
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
PHASE2
COMPLETED
NCT00022477
INTERVENTIONAL
A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Advanced Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent or metastatic colorectal cancer.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* The following are not considered measurable lesions:
* Lesions seen on colonoscopic examination or barium study
* Bone metastases
* CNS lesions
* Ascites
* Failed prior combination therapy comprising fluorouracil, leucovorin calcium, and irinotecan for metastatic disease
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT/AST no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No grade 2 or greater peripheral neuropathy
* No history of allergic hypersensitivity reaction to compounds containing polyoxyethylated castor oil (Cremophor EL) (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
* No other currently active malignancy (less than 30% risk of relapse and completed prior therapy) except non-melanoma skin cancer or carcinoma in situ of the cervix
* No uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
* No concurrent colony-stimulating factors during first course of therapy
Chemotherapy:
* See Disease Characteristics
* Prior adjuvant chemotherapy allowed
* At least 4 weeks since prior cytotoxic chemotherapy and recovered
* No more than 1 prior chemotherapy regimen for metastatic disease
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent anticancer hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent therapeutic radiotherapy
Surgery:
* See Disease Characteristics
* At least 4 weeks since prior surgery
Other:
* At least 30 days since prior investigational agents
* At least 7 days since prior cimetidine
* No other concurrent anticancer investigational agents, commercial agents, or therapies
* No concurrent unconventional therapy, food, or vitamin supplement containing Hypericum perforatum (St. John's Wort)
* No concurrent cimetidine
* No concurrent combination antiretroviral therapy for HIV-positive patients
Colorectal Cancer
- TREATMENT
-
- Type: DRUG
- Name: BMS-247550
- Description:
- Arm Group Labels: BMS-247550
- University of Chicago