Clinical trial NCT00193258: Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Keywords: Recurrent clear cell renal cell carcinoma
Bevacizumab
Erlotinib
Imatinib
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Novartis
First posted: 2005-09-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.