AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma
|Advanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma||Biological: rilotumumab Drug: cisplatin Drug: pemetrexed disodium Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of AMG 102 in Combination With Pemetrexed and Cisplatin in Patients With Malignant Pleural Mesothelioma|
- Progression-free survival [ Time Frame: From registration to clinical evidence of disease progression or death without progression, assessed up to 3 years ]
- Toxicity defined as a grade 4 hemorrhagic event or a grade 5 event [ Time Frame: Up to 30 days after completion of study treatment ]Graded using the NCI CTCAE.
|Study Start Date:||April 2010|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (rilotumumab, cisplatin, pemetrexed disodium)
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.
Other Names:Drug: cisplatin
Other Names:Drug: pemetrexed disodium
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105390
|Principal Investigator:||James Stevenson||Eastern Cooperative Oncology Group|