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Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00684996
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab and MEDI-522, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and MEDI-522 may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without MEDI-522 in treating kidney cancer.

PURPOSE: This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unresectable or metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: bevacizumab
Drug: etaracizumab
Phase I
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Bevacizumab MEDI-522 Vitaxin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A PHASE I AND A RANDOMIZED PHASE II STUDY OF MAXIMAL ANGIOGENIC BLOCKADE IN ADVANCED RENAL CARCINOMA: BEVACIZUMAB (NSC-704865) WITH OR WITHOUT MEDI-522 (NSC-719850)

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

Primary Outcome Measures:
  • Maximum tolerated dose of bevacizumab (Phase I) [ Designated as safety issue: Yes ]
  • Progression-free survival (Phase II) [ Designated as safety issue: No ]
  • Toxicity (Phase II) [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: June 2008
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phase II Arm I: Active Comparator
Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
Drug: bevacizumab
Given IV
Drug: etaracizumab
Given IV
Phase II Arm II: Active Comparator
Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
Drug: etaracizumab
Given IV

Detailed Description:

OBJECTIVES:

  • To assess the appropriate dose of bevacizumab when administered with humanized monoclonal antibody MEDI-522 in patients with unresectable or metastatic renal cell carcinoma previously treated with sunitinib malate or sorafenib tosylate. (Phase I)
  • To compare the progression-free survival of these patients treated with bevacizumab with versus without humanized monoclonal antibody MEDI-522. (Phase II)
  • To evaluate the qualitative and quantitative toxicities of bevacizumab and humanized monoclonal antibody MEDI-522 in these patients. (Phase II)
  • To estimate overall survival and RECIST response rate (i.e., confirmed and unconfirmed, complete and partial responses) in both treatment arms. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of bevacizumab followed by a randomized phase II study.

  • Phase I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
  • Phase II: Patients are stratified according to the number of prior treatment regimens for renal cell carcinoma (1 vs 2) and whether there is a clear cell component (yes vs no). Patients are randomized to 1 of 2 treatment arms:

    • Arm I: Patients receive bevacizumab (10 mg/kg) IV over 30-90 minutes on days 1 and 15.
    • Arm II: Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8 mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 3 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma

    • Metastatic or unresectable disease
  • Must have received prior sunitinib malate or sorafenib tosylate for metastatic or unresectable disease
  • Measurable disease

    • No soft tissue disease that has been irradiated within the past 2 months
  • More than 6 months since prior and no concurrent treated or untreated brain metastases

    • Stable, treated brain metastases allowed provided they remained stable for more than 6 months
    • Patients with clinical evidence of brain metastases must have a negative brain CT or MRI scan for metastatic disease

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour collection
  • Not be pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
  • No serious or non-healing wound, ulcer, or bone fracture
  • No clinically relevant bleeding diathesis or coagulopathy
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • No New York Heart Association class II-IV congestive heart failure
  • No unstable symptomatic arrhythmia requiring medication

    • Chronic, controlled arrhythmias (e.g., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
  • No clinically significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)
  • None of the following cardiovascular conditions within the past 6 months:

    • Arterial thrombosis
    • Unstable angina
    • Myocardial infarction
    • Cerebrovascular accident
  • Must have controlled blood pressure, defined as systolic blood pressure (BP) ≤ 160 mm Hg and/or diastolic BP ≤ 90 mm Hg

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 7 days since prior core biopsy
  • At least 14 days since completion of prior therapy and recovered
  • At least 28 days since prior radiotherapy and recovered

    • No prior radiotherapy to ≥ 25% of bone marrow
  • No more than two prior systemic regimens for renal cell carcinoma (including adjuvant treatment)
  • No prior bevacizumab or humanized monoclonal antibody MEDI-522
  • No major surgical procedure or open biopsy within the past 28 days
  • No concurrent need for a major surgical procedure
  • Concurrent full-dose anticoagulation with warfarin allowed provided INR is between 2-3

    • Concurrent low molecular weight heparin allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684996

Locations
United States, California
Tibotec Therapeutics - Division of Ortho Biotech Products, LP Recruiting
Marysville, California, United States, 95901
Contact: Primo N. Lara, Jr.     908-541-4500        
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive     800-865-1125        
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt     704-384-5369        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
United States, Virginia
Danville Regional Medical Center Recruiting
Danville, Virginia, United States, 24541
Contact: Clinical Trials Office - Danville Regional Medical Center     434-799-3753        
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Christopher W. Ryan, MD Oregon Health and Science University Cancer Institute
Investigator: Theresa M. Koppie, MD University of California, Davis
Investigator: Philip C. Mack, PhD University of California, Davis
  More Information

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

Study ID Numbers: CDR0000596555, SWOG-S0717
Study First Received: May 24, 2008
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00684996  
Health Authority: Unspecified

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

Study placed in the following topic categories:
Urogenital Neoplasms
Bevacizumab
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009