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BMS-247550 in Treating Patients With Metastatic Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about BMS-247550 in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and BMS-247550 in Treating Patients With Metastatic Colorectal Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as BMS-247550 in Treating Patients With Metastatic Colorectal Cancer. BMS-247550 in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a BMS-247550 in Treating Patients With Metastatic Colorectal Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their BMS-247550 in Treating Patients With Metastatic Colorectal Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Metastatic Colorectal Cancer  BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,recurrent rectal cancer,Stage 4 rectal cancer,stage 4 colon cancer,adenocarcinoma of the rectum,adenocarcinoma of the colon
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , UAB Comprehensive Cancer 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 metastatic colorectal cancer.
Details: OBJECTIVES: I. Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan. II. Determine the safety of this drug in these patients. III. Determine the response duration, time to progression, and survival in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4 additional courses of treatment beyond CR. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for this study within 6 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 colorectal adenocarcinoma Prior treatment for metastatic disease with at least: - One regimen of irinotecan in combination with a fluoropyrimidine OR - Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy [May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy] Disease progression during or within 4 months of treatment with irinotecan At least 1 bidimensionally measurable lesion No known CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: - See Disease Characteristics - No concurrent immunotherapy - No growth factors for 24 hours before and after cytotoxic chemotherapy Chemotherapy: - See Disease Characteristics - Additional prior adjuvant or neoadjuvant chemotherapy allowed - At least 4 weeks since prior chemotherapy and recovered - No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease - No prior oxaliplatin - No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except hormone replacement therapy Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy - No concurrent therapeutic radiotherapy [Focal radiotherapy for palliation of bone symptoms may be allowed] Surgery: At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered Other: No other concurrent experimental anticancer medications --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 2,000/mm3 - Platelet count greater than 125,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease - No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known prior severe hypersensitivity reactions to agents containing Cremophor EL - No motor or sensory neuropathy grade 2 or greater - No concurrent serious uncontrolled infection or other nonmalignant medical illness - No concurrent psychiatric disorders or other conditions that would preclude study - No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndresForero-Torres, Study Chair, UAB Comprehensive Cancer Center
Georgia Cancer Specialists
Atlanta, Georgia, 30342
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Additional Information:
Study ID Numbers: CDR0000069272; UAB-F011029021,UAB-0145,BMS-CA163-012,NCI-G02-2051
Study Start Date: February 2002
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033306
Other Adenocarcinoma Of The Rectum Studies:
1. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
2. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
4. Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
5. G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Related Studies:
Other adenocarcinoma of the rectum Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
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