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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 Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Participants frequently get the best healthcare available for their 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 condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > 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  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
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
For Condition: adenocarcinoma of the colon,adenocarcinoma of the rectum,recurrent rectal cancer,Stage 4 rectal cancer,recurrent colon cancer,stage 4 colon cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of SU011248 in treating patients who have metastaticcolorectaladenocarcinoma (cancer) that has not responded to previous treatment with irinotecan, oxaliplatin, and a fluoropyrimidine (such as fluorouracil) with or without bevacizumab.
Details: OBJECTIVES: Primary - Determine the antitumor efficacy of SU011248 in patients with metastatic colorectal adenocarcinoma who failed prior treatment with irinotecan, oxaliplatin, and a fluoropyrimidine with or without bevacizumab. Secondary - Determine the onset and duration of tumor control and 1-year survival rate in patients treated with this drug. - Determine the safety of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior bevacizumab (yes vs no). Patients receive oral SU011248 once daily on days 1-28. Courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 2 months for 1 year. PROJECTED ACCRUAL: A total of 76-126 patients (38-63 per stratum) 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 adenocarcinoma not amenable to surgery, radiotherapy, or combined modality therapy with curative intent - Must have received prior irinotecan, oxaliplatin, and a fluoropyrimidine in the adjuvant and/or advanced disease setting with or without bevacizumab (in the advanced disease setting) AND developed resistance to these prior therapies, as defined by one of the following: - Irinotecan-, oxaliplatin-, or fluoropyrimidine-resistant disease, defined as relapse or progression during treatment OR within 6 months after completing the most recent regimen - Bevacizumab-resistant disease, defined as disease progression during treatment OR within 6 months after completing bevacizumab - At least one unidimensionally measurable lesion at least 20 mm by conventional radiographic techniques or MRI OR at least 10-16 mm by spiral CT scan - The following lesions are not considered measurable: - Bone lesions - Ascites - Peritoneal carcinomatosis or miliary lesions - Pleural or pericardial effusions - Lymphangitis of the skin or lung - Cystic lesions - Irradiated lesions - Disease documented by indirect evidence only (e.g., by laboratory test, such as alkaline phosphatase) - No known brain or leptomeningeal disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9.0 g/dL Hepatic - AST and ALT 2.5 times upper limit of normal (ULN) (5 times ULN if abnormalities are due to underlying malignancy) - Albumin 3.0 g/dL - Bilirubin 1.5 times ULN - PT and PTT 1.5 times ULN Renal - Creatinine 1.5 times ULN Cardiovascular - LVEF above lower limit of normal by MUGA - No ongoing cardiac dysrhythmias grade 2 - No atrial fibrillation of any grade - No prolongation of the QTc interval to > 450 msec (for males) or > 470 msec (for females) - None of the following conditions within the past 12 months: - Myocardial infarction - Severe/unstable angina - Symptomatic congestive heart failure - Cerebrovascular accident - Transient ischemic attack - Deep vein thrombosis - Other thromboembolic event Pulmonary - No pulmonary embolism within the past 12 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Amylase and lipase ULN - Adrenocorticotrophic hormone stimulation test normal - No known HIV infection - No AIDS-related illness - No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 3 weeks since prior immunotherapy and recovered - No prior vascular endothelial growth factor inhibitors (except bevacizumab) - No concurrent biological response modifiers - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy - No more than 3 prior systemic chemotherapy-based regimens for advanced disease - Prior chemoembolization therapy allowed provided areas of measurable disease are not affected - No concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - Areas of measurable disease must not be affected - No concurrent radiotherapy to the sole site(s) of measurable disease - Concurrent palliative radiotherapy allowed provided the measurable lesions (study target lesions) are not included in the irradiated field Surgery - Recovered from prior surgery - Prior surgery allowed provided areas of measurable disease are not affected - More than 12 months since prior coronary/peripheral artery bypass graft - No concurrent surgery in the sole site(s) of measurable disease Other - Prior intrahepatic therapy or cryotherapy allowed provided areas of measurable disease are not affected - No prior tyrosine kinase inhibitors (except bevacizumab) - No other concurrent anticancer treatment - No other concurrent investigational drugs - No concurrent participation in another clinical trial
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 Ghassan Abou-Alfa 212-639-3112
Additional Information:
Study ID Numbers: CDR0000360732; MSKCC-03143,PFIZER-A6181003,PFIZER-PHA-RTKC-0511
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082771
Other Adenocarcinoma Of The Colon Studies:
1. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
2. G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
3. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
4. Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
5. Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
Related Studies:
Other adenocarcinoma of the colon Clinical Trials
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Other New York City Clinical Trials
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
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