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VEGF Trap in Treating Patients With Metastatic or Unresectable Kidney Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00357760
  Purpose

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
Kidney Cancer
Drug: aflibercept
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Aflibercept
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival rate at 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Response duration [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

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
Arm A: Experimental
Patients receive a higher dose of VEGF Trap IV over 1 hour on day 1.
Drug: aflibercept
High or lower dose given IV
Arm B: Experimental
Patients receive a lower dose of VEGF Trap IV over 1 hour on day 1.
Drug: aflibercept
High or lower dose given IV

Detailed Description:

OBJECTIVES:

Primary

  • Compare the effect of two different doses of VEGF Trap on the progression-free survival rate at 8 weeks in patients with metastatic or unresectable renal cell carcinoma previously treated with a tyrosine kinase inhibitor.

Secondary

  • Compare the effect of two different doses of VEGF Trap on objective response rate in these patients.
  • Describe progression-free survival among patients who undergo dose escalation after progression on low-dose VEGF Trap.
  • Evaluate the safety and tolerability of VEGF Trap in these patients.
  • Correlate the circulating levels of VEGF Trap complex with clinical activity.
  • Evaluate the modulation of specific angiogenesis-related protein expression by VEGF Trap.

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.

  • Arm A: Patients receive a higher dose of VEGF Trap IV over 1 hour on day 1.
  • Arm B: Patients receive a lower dose of VEGF Trap IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receiving treatment on arm I may crossover and receive treatment on arm II if disease progression is evident after 4 courses of treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic or unresectable renal cell carcinoma

    • Disease must be conventional clear cell carcinoma or have a component of conventional clear cell renal carcinoma
    • The following cellular subtypes are NOT eligible:

      • True papillary carcinoma
      • Sarcomatoid features without any clear cell component
      • Chromophobe
      • Oncocytoma
      • Collecting duct tumors
      • Transitional cell carcinoma
  • Receptor tyrosine kinase inhibitor (TKI)-resistant disease

    • Must have received one (and only one) prior treatment with either sunitinib malate (Sutent) or sorafenib (Nexavar) for ≥ 3 months
    • Treatment with TKI must have ended ≥ 1 week prior to study treatment and all toxicities must have resolved
  • Measurable lesions
  • Must have evidence of progressive disease by CT scan and other appropriate clinical documentation
  • No history of CNS metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Calcium ≤ 12.0 mg/dL
  • INR normal (or ≤ 1.5 times ULN if on prophylactic anticoagulation)
  • aPTT normal
  • Creatinine clearance ≥ 60 mL/min
  • Proteinuria ≤ 500 mg by 24-hour urine collection OR urine protein:creatinine ratio ≤ 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • None of the following conditions within the past 6 months:

    • Myocardial infarction
    • Severe/unstable angina pectoris
    • Coronary/peripheral artery bypass graft
    • New York Heart Association class III or IV congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
  • No prior pulmonary embolism, deep vein thrombosis, or other thromboembolic event
  • No history of uncontrolled or labile hypertension (with or without antihypertensive drug treatment), defined as any of the following:

    • Blood pressure > 150/100 mm Hg
    • Systolic blood pressure > 180 mm Hg on ≥ 2 repeated determinations on separate days within the past 3 months
  • No known active infection or bleeding, intratumoral bleeding, or underlying bleeding disorder
  • No known history of hypersensitivity to any Trap agents or recombinant proteins
  • No HIV-positive patients receiving combination anti-retroviral therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior radiotherapy or surgery within 4 weeks prior to randomization
  • Prior immunotherapy limited to cytokine therapy with aldesleukin (interleukin-2) or interferon alfa allowed
  • No prior chemotherapy, cellular therapy, vaccine therapy, or hormonal therapy
  • Prior radiotherapy is allowed provided there is measurable disease outside the radiotherapy port

    • At least 3 weeks since prior radiotherapy
  • No other concurrent systemic anticancer agents
  • No other concurrent investigational therapies or devices
  • No concurrent corticosteroids except as replacement therapy for patients who have previously received suppressive doses or who have adrenal insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357760

  Show 183 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Roberto Pili, MD Sidney Kimmel Comprehensive Cancer Center
Investigator: Michael A. Carducci, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000489069, ECOG-E4805
Study First Received: July 26, 2006
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00357760  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
clear cell renal cell carcinoma
recurrent renal cell cancer
stage III renal cell cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009