A Phase II Trial of Tarceva (Erlotinib) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Melanoma
- Determine the overall response rate, response duration, and frequency of
progression-free survival at 6 months in patients with stage IV melanoma treated with
erlotinib hydrochloride and bevacizumab.
- Determine objective responses in patients treated with this regimen.
- Determine the overall safety and tolerability of this regimen in these patients.
- Evaluate tissue blocks for EGFR by monoclonal antibody H11 (DAKO) or fluorescence in
situ hybridization(FISH)7p12-specific probe-overexpression or amplification in patients
treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV
over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 (DAKO) or
fluorescence in situ hybridization (FISH) 7p12-specific probe-overexpression or
amplification. Biological markers AKT, MAPK, p27, p21, CD13, CD34, and factor VIII are also
After completion of study treatment, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Response
Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
At 6 months
Jeffrey A. Sosman, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC MEL 0418
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|