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

Primary Purpose

Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
semaxanib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Renal Cell Cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (semaxanib)

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of progression-free events
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Objective response rate
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.

Secondary Outcome Measures

Survival
Analyzed using Kaplan Meier curves and Cox proportional hazards models.
Time to disease progression
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time to treatment failure
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Duration of response
Analyzed using Kaplan Meier curves and Cox proportional hazards.

Full Information

First Posted
February 2, 2001
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00009919
Brief Title
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
Official Title
Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
December 2000 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (semaxanib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
semaxanib
Other Intervention Name(s)
semoxind, SU5416, Sugen 5416
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Rate of progression-free events
Description
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Time Frame
6 months
Title
Objective response rate
Description
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Survival
Description
Analyzed using Kaplan Meier curves and Cox proportional hazards models.
Time Frame
Up to 3 years
Title
Time to disease progression
Description
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time Frame
Up to 3 years
Title
Time to treatment failure
Description
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time Frame
Up to 3 years
Title
Duration of response
Description
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Siefker-Radtke
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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