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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193258
First received: September 12, 2005
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Clear Cell Renal Cell Carcinoma
Drug: Bevacizumab
Drug: Erlotinib
Drug: Imatinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: June 2004
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193258

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

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193258     History of Changes
Other Study ID Numbers: SCRI GU 22
Study First Received: September 12, 2005
Results First Received: December 7, 2012
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Recurrent clear cell renal cell carcinoma
Bevacizumab
Erlotinib
Imatinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Bevacizumab
Erlotinib
Imatinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014