SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: semaxanib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: semaxanib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum