Expired Study
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New York, New York 10021


Purpose:

RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well SU011248 works in treating patients with metastatic colorectal adenocarcinoma (cancer) that has not responded to previous treatment with irinotecan, oxaliplatin, and a fluoropyrimidine (such as fluorouracil) with or without bevacizumab.


Study summary:

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.


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


NCT ID:

NCT00082771


Primary Contact:

Study Chair
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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