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BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical research trials and BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer. BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer clinical trial. Subjects often receive the most expert healthcare possible for their BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer  BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
For Condition: stage 4 colon cancer,adenocarcinoma of the rectum,adenocarcinoma of the colon,recurrent rectal cancer,recurrent colon cancer,Stage 4 rectal cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550. II. Determine the toxicity of this drug in these patients. III. Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 St. John's Wort - No concurrent cimetidine - No concurrent combination antiretroviral therapy for HIV-positive patients --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46601
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Additional Information:
Study ID Numbers: CDR0000068821; NCI-3670,UCCRC-11003B
Study Start Date: September 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022477
Other Adenocarcinoma Of The Colon Studies:
1. Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
2. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
4. BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Related Studies:
Other adenocarcinoma of the colon Clinical Trials
Other Illinois Clinical Trials
Other Evanston Clinical Trials
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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