A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma

Genentech, Inc.20 sites in 1 country100 target enrollmentMarch 2004

ConditionsRenal Cell Carcinoma Metastases

DrugsAvastin (bevacizumab)Tarceva (erlotinib HCl)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Genentech, Inc.
Enrollment: 100
Locations: 20
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

July 2005

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Histologically confirmed RCC of clear cell histology
•Confirmed metastatic RCC
•Age \>=18 years
•ECOG performance status of 0 or 1
•Life expectancy \>=3 months
•Prior nephrectomy
•Measurable disease, as defined by RECIST
•Use of an acceptable means of contraception (potentially fertile men and women)

Exclusion Criteria

•RCC with predominantly sarcomatoid features
•Prior systemic or adjuvant therapy for RCC
•Prior radiotherapy for RCC within 28 days prior to Day 0, with the exception of single fraction radiotherapy given for the indication of pain control
•Treatment with Avastin, Tarceva, or other agents, either investigational or marketed, that act by either EGFR inhibition or anti-angiogenesis mechanisms
•24-hour urine collection with \>=1 g of protein
•INR \>=1.5, except for subjects receiving warfarin therapy
•Serum creatinine \>2.0 mg/dL
•Serum calcium \>10 mg/dL (corrected)
•Absolute neutrophil count (ANC) \<1500/uL
•Platelet count \<75,000/uL