Colon Cancer Clinical Trial
SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Summary
Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic or locally recurrent colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor.
Full Description
OBJECTIVES:
I. Determine the objective response rate and disease stabilization rates of patients with previously treated metastatic or locally recurrent colorectal cancer treated with SU5416.
II. Determine the median and overall survival and time to progression in this patient population receiving this treatment.
III. Determine the toxicity of SU5416 in these patients.
OUTLINE: This is a multicenter study.
Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 2 weeks for 4 weeks.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-18 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum
Progressive disease as defined by new or progressive radiologic lesions
Measurable disease at least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
Lesions seen on colonoscopic examination or barium studies, bone metastases, CNS lesions, CEA levels and ascites are not considered measurable
Lesion accessible for biopsy which is not within prior radiation port
Known history of CNS metastasis allowed if patients have had treatment, are neurologically stable, and do not require oral or intravenous steroids or anticonvulsants, provided brain scan (CT or MRI) shows absence of active or residual disease
If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required
PATIENT CHARACTERISTICS:
Age: 18 and over
Performance status: WHO 0-2
Life expectancy: At least 12 weeks
WBC at least 3,000/mm3
Platelet count at least 75,000/mm3
Bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 2.5 times upper limit of normal
Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
No uncompensated coronary artery disease
No history of myocardial infarction or severe/unstable angina within past 6 months
No severe peripheral vascular disease associated with diabetes mellitus
No deep venous or arterial thrombosis within past 3 months
No pulmonary embolism within past 3 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other significant uncontrolled underlying medical or psychiatric illness
No serious active infections
No concurrent second malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix unless completed therapy and considered to be at less than 30% risk of relapse
No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
PRIOR CONCURRENT THERAPY:
No more than 2 prior chemotherapy regimens for metastatic disease
At least 4 weeks since prior chemotherapy
No concurrent chemotherapy
No other concurrent investigational antineoplastic drugs
No prior radiotherapy to only site of measurable disease
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy
At least 30 days since other prior investigational drugs
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There are 10 Locations for this study
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61602, United States
Springfield Illinois, 62701, United States
Fort Wayne Indiana, 46885, United States
South Bend Indiana, 46617, United States
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