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Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer Clinical research trials and Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer  Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,recurrent rectal cancer,stage 4 colon cancer,Stage 4 rectal cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as irinotecan, also work in different ways to kill cancer cells or stop them from growing. Combining cetuximab and bevacizumab with irinotecan may improve the ability to block cancer growth. PURPOSE: Randomizedphase II trial to compare the effectiveness of bevacizumab and cetuximab with or without irinotecan in treating patients who have irinotecan-refractorymetastaticcolorectal cancer.
Details: OBJECTIVES: - Evaluate time to tumor progression in patients with irinotecan-refractory metastatic colorectal cancer treated with bevacizumab and cetuximab with or without irinotecan. - Evaluate objective response rate in patients treated with these regimens. - Evaluate overall survival of patients treated with these regimens. - Evaluate safety, tolerability, and adverse event profiles of these regimens in these patients. - Correlate a panel of molecular markers (e.g., those involved in the epidermal growth factor receptor signaling pathway, angiogenic pathway, and irinotecan metabolism) with clinical outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 vs 1), and albumin (> 3.0 g/dL vs ≤ 3.0 g/dL). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cetuximab IV over 1 hour on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1. - Arm II: Patients receive cetuximab as in arm I and bevacizumab IV over 30-90 minutes on days 1*, 15, and 29. NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses. In both arms, courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed colorectal cancer - Metastatic disease by diagnostic imaging studies - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Refractory* to irinotecan, evidenced by clinical documentation of 1 of the following: - Received at least 1 prior irinotecan-containing chemotherapy regimen for metastatic disease and progressed during or within 3 months after completion of therapy - Received a prior adjuvant irinotecan-containing regimen and progressed during or within 6 months after completion of adjuvant therapy NOTE: *Tumor marker (e.g., carcinoembryonic antigen [CEA]) elevation alone is not considered adequate evidence of treatment failure - Must have received prior irinotecan according to 1 of the following schedules: - Weekly administration with a starting dose of 100-125 mg/m^2 - Biweekly administration (every other week) with a starting dose of approximately 180 mg/m^2 - Once every three weekly administration with a starting dose of 300-350 mg/m^2 - No known brain metastases - No prior primary CNS tumors PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 OR - Karnofsky 80-100% Life expectancy - More than 3 months Hematopoietic - WBC 3,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9 g/dL - No bleeding diathesis or coagulopathy Hepatic - Bilirubin normal - AST and ALT 2.5 times upper limit of normal (ULN) (5 times ULN in the presence of known liver metastases) - INR < 1.5 (for patients receiving warfarin) Renal - Creatinine ULN OR - Creatinine clearance 60 mL/min - No proteinuria* NOTE: *Patients with 1+ proteinuria at baseline must have protein < 500 mg/24-hour urine collection Cardiovascular - No prior stroke - No symptomatic congestive heart failure - No unstable angina pectoris - No uncontrolled hypertension - No clinically significant cardiac arrhythmia - No myocardial infarction 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 28 days - No grade 3 or greater neurotoxicity - No uncontrolled seizures - No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents - No prior irinotecan intolerance - No ongoing or active infection requiring parenteral antibiotics - No serious nonhealing active wound, ulcer, or bone fracture - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled illness that would preclude study participation - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies PRIOR CONCURRENT THERAPY: Biologic therapy - No prior cetuximab - No other prior epidermal growth factor receptor-directed therapy - No prior anticancer murine or chimeric monoclonal antibody therapy - Prior humanized monoclonal antibody therapy allowed - No prior bevacizumab - No other prior vascular endothelial growth factor-targeted therapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - More than 28 days since prior major surgical procedure or open biopsy Other - Recovered from all prior therapy - Any number of prior standard or investigational regimens allowed - No other concurrent investigational agents - No other concurrent anticancer therapy - No recent or concurrent thrombolytic agents - No recent or concurrent full-dose warfarin except as required to maintain patency of preexisting, permanent indwelling IV catheters - No concurrent therapeutic heparin - Concurrent prophylactic low-molecular weight heparin allowed - No concurrent chronic daily aspirin (> 325 mg/day) - No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet function - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonardSaltz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Leonard Saltz 212-639-2501
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Paulo Hoff 713-792-2828
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Hedy Kindler 773-702-0360
Additional Information:
Study ID Numbers: CDR0000350086; MSKCC-03135,NCI-6444
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077298
Other Stage 4 Colon Cancer Studies:
1. R115777 in Treating Patients With Advanced Colorectal Cancer
2. SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
3. Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
4. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
5. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
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