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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer  Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): Genentech ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without bevacizumab in treating colorectal cancer. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have metastatic colorectal cancer.
Details: OBJECTIVES: I. Compare the efficacy of fluorouracil and leucovorin calcium with and without bevacizumab, in terms of duration of survival, objective response rate, duration of response, time to disease progression, and change in quality of life, in patients with previously untreated metastatic colorectal cancer. II. Compare the safety of these regimens in these patients. III. Assess the safety and preliminary efficacy of bevacizumab combined with irinotecan in these patients. IV. Assess the pharmacokinetics of irinotecan in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind, active-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1 or higher), site of primary disease (colon vs rectum), and number of metastatic sites (1 vs more than 1). Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour weekly for the first 6 weeks of each 8 week course. Study drug, bevacizumab is administered IV over 30-90 minutes every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive leucovorin calcium and fluorouracil as in arm I and placebo IV over 30-90 minutes every 2 weeks. Treatment continues for up to a total of 48 doses of bevacizumab or a maximum of 96 weeks of therapy. Patients on arm I who have disease progression may continue bevacizumab with or without irinotecan IV over 90 minutes weekly for 4 weeks, with courses repeating every 6 weeks. Patients on arm II who have disease progression may not receive second-line bevacizumab. Patients on either arm who have disease progression may receive irinotecan alone as second-line treatment. Quality of life is assessed every 3-5 weeks. Patients are followed every 4 months for survival. PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, previously untreated, metastatic colorectal carcinoma - Bidimensionally measurable disease (minimum of two lesions) - Not an optimal candidate for first-line irinotecan - Must meet at least one of the following criteria: Age 65 years or over; ECOG performance status 1-2; Albumin no greater than 3.5 g/dL; Prior radiotherapy to the abdomen or pelvis - No CNS disease (e.g., primary brain tumor, seizures not controlled with standard therapy, or any brain metastases) - No clinically detectable ascites --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy for colorectal cancer; No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 12 months since prior adjuvant fluoropyrimidines in combination with leucovorin calcium and/or levamisole; No other prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No prior radiotherapy to target lesions; At least 12 months since prior administration of fluoropyrimidines as a radiosensitizer during pelvic radiotherapy for rectal cancer completed less than 12 months prior to study; At least 14 days since prior radiotherapy; No concurrent radiotherapy - Surgery: At least 28 days since prior major surgery; At least 7 days since prior fine needle aspiration; No concurrent open biopsy or anticipated need for major surgery - Other: At least 10 days since prior chronic use of oral or parenteral anticoagulants (except as needed to maintain patency of indwelling IV catheters) or thrombolytic agents; At least 28 days since participation in other experimental drug study; No concurrent oral or parenteral anticoagulants (except as needed to maintain patency of indwelling IV catheters) or thrombolytic agents; No concurrent chronic daily aspirin or nonsteroidal anti-inflammatory medications known to inhibit platelet function --Patient Characteristics-- - Age: See Disease Characteristics; 18 and over - Performance status: See Disease Characteristics; ECOG 0-2 - Life expectancy: More than 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count greater than 75,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed); No bleeding diathesis or coagulophathy - Hepatic: See Disease Characteristics; Bilirubin no greater than 2.0 mg/dL; AST/ALT no greater than 2.5 times upper limit of normal (ULN)(less than 5 times ULN if liver metastases present); INR less than 1.5 - Renal: No history of proteinuria; No clinically significant impairment of renal function; Creatinine no greater than 2.0 mg/dL - Cardiovascular: No uncontrolled hypertension, myocardial infarction, or unstable angina within the past year; No New York Heart Association class II or higher congestive heart failure within the past year; No serious cardiac arrhythmia requiring medication or grade II or higher peripheral vascular disease within the past year - Other: Able to tolerate CT scan contrast dye; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 5 years except basal cell carcinoma of the skin; No serious nonhealing wound, ulcer, significant traumatic injury, or bone fracture; No concurrent active infection requiring parenteral antibiotics; No metabolic dysfunction or other medical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrentPerrou, Study Chair, Genentech
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
US Oncology - Tyler Cancer Center
Tyler, Texas, 75702
United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43222
United States
US Oncology - Ocala Oncology, PA
Ocala, Florida, 34470
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
Veterans Affairs Medical Center - Columbia
Columbia, South Carolina, 20209
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
US Oncology - Texas Oncology, PA
Ft. Worth, Texas, 76104-3902
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Cancer Research of Long Island, Inc.
Great Neck, New York, 11022
United States
US Oncology - Triad Hematology-Oncology
Winston Salem, North Carolina, 27103
United States
Oncology Radiation Associates
Miami, Florida, 33133
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Billings Oncology Associates
Billings, Montana, 59101
United States
US Oncology - South Texas Cancer Center - McAllen
McAllen, Texas, 78503-1298
United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
United States
US Oncology - Florida Community Cancer Centers
New Port Richey, Florida, 34652
United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Missouri Cancer Care, P.C.
St. Charles, Missouri, 63301
United States
Advanced Oncology Associates
Armonk, New York, 10504
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
Associates in Oncology and Hematology
Rockville, Maryland, 20850
United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
United States
US Oncology - Florida Community Cancer Centers
Palm Harbor, Florida, 34684
United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
United States
US Oncology - Florida Community Cancer Center
Clearwater, Florida, 33761
United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
United States
US Oncology - Texas Cancer Center
Ft. Worth, Texas, 76104-2343
United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
United States
US Oncology - Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, 01201
United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, 28603
United States
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, 18510
United States
Piedmont Hospital, Inc.
Atlanta, Georgia, 30309
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32803
United States
US Oncology - Dayton Oncology-Hematology Consultants
Dayton, Ohio, 45439
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
Florida Community Cancer Center
Hudson, Florida, 34667
United States
US Oncology - Virginia Oncology Associates
Newport News, Virginia, 23606
United States
Mesa Cancer Resource Network
Mesa, Arizona, 85201
United States
US Oncology - North Texas Regional Cancer Center
Plano, Texas, 75075-7787
United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
US Oncology
Dallas, Texas, 75246
United States
US Oncology - North Florida Hematology & Oncology Association
Jacksonville, Florida, 32204
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
US Oncology - Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80907
United States
US Oncology - Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
United States
US Oncology - Texas Oncology, PA
Dallas, Texas, 75246
United States
Rhinelander Medical Center
Rhinelander, Wisconsin, 54501
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
US Oncology - Albany Regional Cancer Center
Albany, New York, 12208
United States
US Oncology - Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80538
United States
US Oncology - Lauderhill Lakes
Plantation, Florida, 33324
United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
United States
South Carolina Oncology Associates
Columbia, South Carolina, 29203
United States
Carroll County Cancer Center
Westminster, Maryland, 21157
United States
US Oncology - Cancer Care Associates
Tulsa, Oklahoma, 74136-1902
United States
Cancer Research Network Inc.
Plantation, Florida, 33324
United States
Additional Information:
Study ID Numbers: CDR0000068499; GENENTECH-AVF2192g
Study Start Date: June 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012272
Other Stage 4 Colon Cancer Studies:
1. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
2. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
3. Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
4. Gemcitabine in Treating Patients With Advanced Colorectal Cancer
5. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Texas Clinical Trials
Other Plano Clinical Trials
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
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