Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma
1 other identifier
interventional
94
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2004
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
January 14, 2013
CompletedJanuary 31, 2013
January 1, 2013
6.6 years
September 12, 2005
December 7, 2012
January 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
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.
18 months
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
18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
24 months
Study Arms (1)
Intervention
EXPERIMENTALIn 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
Interventions
400-600mg daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
- Novartiscollaborator
Related Publications (1)
Hainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030.
PMID: 18272024RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
June 1, 2004
Primary Completion
January 1, 2011
Study Completion
August 1, 2011
Last Updated
January 31, 2013
Results First Posted
January 14, 2013
Record last verified: 2013-01