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Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00193258
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : January 14, 2013
Last Update Posted : January 31, 2013
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Description
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Brief Summary:
This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Drug: Bevacizumab Drug: Erlotinib Drug: Imatinib Phase 1 Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

Bevacizumab + Erlotinib + Imatinib

A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma
Study Start Date : June 2004
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention

In the phase I portion:

Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course

Erlotinib 150 mg orally daily

Imatinib 300 mg orally daily or 400 mg orally daily

In the phase II portion:

Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle

Erlotinib 150 mg orally daily

Imatinib 400 mg orally daily

 Drug: Bevacizumab
10mg/kg IV infusion every 2 weeks
Other Name: Avastin

Drug: Erlotinib
150 mg po daily
Other Name: Tarceva

Drug: Imatinib
400-600mg daily
Other Name: STI571, Gleevec, Glivec, imatinib mesilate (INN)


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2. Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]
  3. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy
  • Previous nephrectomy is required
  • Maximum of 1 previous systemic regimen for metastatic disease.
  • Able to perform activities of daily living with minimal assistance
  • Measurable disease
  • Adequate bone marrow, liver and kidney
  • Written informed consent.

Exclusion Criteria:

  • Age < 18 years
  • Treatment with more than 1 previous systemic regimen
  • History of heart attack within 6 months
  • Clinically significant cardiovascular disease
  • Moderate to severe vascular disease.
  • Active brain metastases.
  • History or evidence by physical examination of brain tumor
  • Seizures not controlled with standard medical therapy
  • history of stroke or other serious disorders of the nervous system
  • Clinical history of coughing or vomiting blood within the past 3 months.
  • PEG tubes or G tubes
  • Chronic therapy with NSAIDS or other platelet inhibitors
  • Proteinuria
  • Nonhealing wound, ulcer, or long bone fracture
  • Clinical evidence or history of a bleeding disorder
  • Requiring full dose anticoagulation with coumadin
  • Receiving chronic steroid therapy
  • Significant medical conditions.
  • Tumors other than clear cell
  • History of stroke within 6 months.
  • History of abdominal fistula,perforation,or abscess within 6 months.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193258


Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Novartis
Investigators
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Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
More Information
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Additional Information:

Publications of Results:

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193258    
Other Study ID Numbers: SCRI GU 22
First Posted: September 19, 2005    Key Record Dates
Results First Posted: January 14, 2013
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by SCRI Development Innovations, LLC:
Recurrent clear cell renal cell carcinoma
Bevacizumab
Erlotinib
Imatinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
 Erlotinib Hydrochloride
Imatinib Mesylate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action