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Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy Clinical research trials and Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy. Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy  Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
For Condition: Stage 4 rectal cancer,adenocarcinoma of the colon,recurrent rectal cancer,recurrent colon cancer,stage 4 colon cancer,adenocarcinoma of the rectum
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.
Details: OBJECTIVES: - Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy. - Determine the time to progression and overall survival of patients treated with this regimen. - Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens. - Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36. - Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44. For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for tumor response and survival. PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study. A total of 35-125 patients will be accrued for this study within 3 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed colorectal adenocarcinoma - Stage IV (metastatic) disease - Not curable by surgery or radiotherapy - Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria: - Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy - Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL (transfusion allowed) - No evidence of bleeding diathesis or coagulopathy Hepatic - Bilirubin no greater than 1.5 mg/dL - AST less than 5 times upper limit of normal (ULN) - Alkaline phosphatase less than 5 times ULN - PT and INR no greater than 1.5 times ULN - PTT no greater than ULN Renal - Creatinine no greater than 1.5 times ULN - Proteinuria less than grade 1 OR - Proteinuria less than 500 mg/24 hours Cardiovascular - No prior stroke - No uncontrolled high blood pressure - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart disease - No thromboembolism within the past 6 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation - No significant traumatic injury within the past 6 weeks - No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents - No active infection - No psychiatric illness or social situation that would preclude study compliance - No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture - No CNS disease, including either of the following: - Primary brain tumor - Seizures not controlled with standard medical therapy PRIOR CONCURRENT THERAPY: Biologic therapy - At least 8 weeks since prior monoclonal antibody therapy - No prior bevacizumab Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy) Surgery - More than 6 weeks since prior major surgical procedure or open biopsy - More than 7 days since prior fine needle aspiration or core biopsy - No concurrent surgery Other - Recovered from prior therapy - At least 3 weeks since prior cytotoxic agents - No concurrent therapeutic anticoagulation - Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met - No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents for the malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HelenChen, Principal Investigator, Investigational Drug Branch
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90024
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Cancer Care of Maine
Bangor, Maine, 04401
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Saint Joseph Mercy Health System
Ann Arbor, Michigan, 48106
United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, 58122
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, 55805
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Sioux Valley Clinics - Oncology
Sioux Falls, South Dakota, 57104
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99519-6604
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Additional Information:
Study ID Numbers: CDR0000320506; CTEP-TRC-0301
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066846
Other Stage 4 Rectal Cancer Studies:
1. Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
2. Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
3. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
4. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Minnesota Clinical Trials
Other Duluth Clinical Trials
Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
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