Study Stopped
Administratively complete.
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
4 other identifiers
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 2, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedFirst Posted
Study publicly available on registry
January 1, 2004
CompletedJanuary 23, 2013
January 1, 2013
2.5 years
February 2, 2001
January 22, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Survival
Up to 3 years
Time to disease progression
Up to 3 years
Time to treatment failure
Up to 3 years
Duration of response
Up to 3 years
Study Arms (1)
Treatment (semaxanib)
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arlene Siefker-Radtke
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2001
First Posted
January 1, 2004
Study Start
December 1, 2000
Primary Completion
June 1, 2003
Last Updated
January 23, 2013
Record last verified: 2013-01