A Phase II Trial of AMG 102 in Combination With Pemetrexed and Cisplatin in Patients With Malignant Pleural Mesothelioma
I. To evaluate the progression-free survival of patients with malignant pleural mesothelioma
(MPM) treated with anti-HGF monoclonal antibody AMG 102 in combination with pemetrexed
disodium and cisplatin.
I. To assess the toxicity associated with this regimen in these patients. II. To determine
the response rate of patients treated with this regimen. III. To determine the overall
survival of patients treated with this regimen. IV. To evaluate multiple potential
correlative biomarkers in MPM that are relevant to this combined regimen, including serum
HGF and mesothelin levels, c-met expression by IHC in tumor specimens, presence of c-met
mutations in tumor, and the presence of thymidylate synthetase (TS) and excision repair
cross complementing protein-1 (ERCC1) polymorphisms.
OUTLINE: This is a multicenter study.
Patients receive anti-HGF monoclonal antibody AMG 102 (AMG 102) IV over 1 hour, pemetrexed
disodium IV over 10 minutes, and cisplatin IV over 1 hour on day 1. Treatment repeats every
21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients without disease progression may continue AMG 102 IV over 1 hour on day 1, every 3
weeks, as maintenance therapy in the absence of disease progression. Some patients undergo
blood sample collection at baseline and periodically during study for correlative biomarker
studies. Tumor samples from diagnostic tissue may also be analyzed.
After completion of study therapy, patients are followed up periodically every 3 months for
2 years and then every 6 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
From registration to clinical evidence of disease progression or death without progression, assessed up to 3 years
Eastern Cooperative Oncology Group
United States: Institutional Review Board