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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00357760 |
RATIONALE: VEGF Trap may stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying two different doses of VEGF Trap to see compare well they work in treating patients with metastatic or unresectable kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: aflibercept |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase II Study to Determine the Effect of 2 Different Doses AVE0005 (VEGF Trap) in Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 120 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
Patients receive a higher dose of VEGF Trap IV over 1 hour on day 1.
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Drug: aflibercept
High or lower dose given IV
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Arm B: Experimental
Patients receive a lower dose of VEGF Trap IV over 1 hour on day 1.
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Drug: aflibercept
High or lower dose given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior cytokine therapy (yes vs no) and Memorial Sloan Kettering Cancer Center (MSKCC) risk (low vs medium vs high). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or unresectable renal cell carcinoma
The following cellular subtypes are NOT eligible:
Receptor tyrosine kinase inhibitor (TKI)-resistant disease
PATIENT CHARACTERISTICS:
None of the following conditions within the past 6 months:
No history of uncontrolled or labile hypertension (with or without antihypertensive drug treatment), defined as any of the following:
PRIOR CONCURRENT THERAPY:
Prior radiotherapy is allowed provided there is measurable disease outside the radiotherapy port
Study Chair: | Roberto Pili, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000489069, ECOG-E4805 |
Study First Received: | July 26, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00357760 |
Health Authority: | Unspecified |
stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer stage III renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |