SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment

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 kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor

Detailed Description
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OBJECTIVES: I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens. II. Determine the changes in tumor perfusion in patients treated with this regimen. III. Determine the time to progression and survival in patients treated with this regimen. OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR. Patients are followed every 3 months.

Official Title
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Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens

Conditions
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Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

Intervention / Treatment
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* Drug: semaxanib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic renal cell carcinoma Prior removal of primary tumors Bidimensionally measurable disease Bone-only disease is not considered measurable Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens No known history of CNS metastasis unless all of the following are true: Previously treated Neurologically stable No requirement for IV steroids or anticonvulsants No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present Performance status - Zubrod 0-2 At least 12 weeks Absolute neutrophil count at least 1,500/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2.5 times upper limit of normal PT and PTT normal Fibrinogen normal D-Dimer assay normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min See Surgery No active congestive heart failure No uncontrolled angina No myocardial infarction or severe/unstable angina within the past 6 months No uncontrolled hypertension No uncompensated coronary artery disease on electrocardiogram or physical examination No severe peripheral vascular disease No deep vein or arterial thrombosis within the past 3 months No pulmonary embolism within the past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No overt psychosis, mental disability, or incompetence No diabetes mellitus No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No hypersensitivity or allergic reaction to paclitaxel See Disease Characteristics No other concurrent anti-cancer biologic therapy See Disease Characteristics No concurrent anti-cancer chemotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No sole indicator lesion within the previously irradiated port No concurrent anti-cancer radiotherapy See Disease Characteristics At least 4 weeks since prior major surgery and recovered At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease No concurrent surgery for cancer No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study

Ages Eligible for Study
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Minimum Age: 16 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: Treatment (semaxanib)<br>Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR receive an additional 6 months of therapy after achieving CR. | Drug: semaxanib<br>* Given IV<br>* Other names: Sugen 5416;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of progression-free events | Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests. | 6 months | 
| Objective response rate | Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Analyzed using Kaplan Meier curves and Cox proportional hazards models. | Up to 3 years | 
| Time to disease progression | Analyzed using Kaplan Meier curves and Cox proportional hazards. | Up to 3 years | 
| Time to treatment failure | Analyzed using Kaplan Meier curves and Cox proportional hazards. | Up to 3 years | 
| Duration of response | Analyzed using Kaplan Meier curves and Cox proportional hazards. | Up to 3 years |