Recurrent Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Trial of AMG 102 in Combination With Pemetrexed and Cisplatin in Patients With Malignant Pleural Mesothelioma
This phase II trial is studying how well giving AMG 102 together with pemetrexed disodium and cisplatin works in treating patients with malignant pleural mesothelioma. Monoclonal antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability of tumor cells to grow or spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AMG 102 together with pemetrexed disodium and cisplatin may kill more tumor cells
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00025207 -
Gefitinib in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
Completed |
NCT00107432 -
Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.
|
Phase 2 | |
Completed |
NCT00027703 -
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
Terminated |
NCT00028782 -
EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
|
N/A | |
Recruiting |
NCT04213794 -
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients
|
Early Phase 1 | |
Completed |
NCT01503177 -
Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
|
Phase 1 | |
Completed |
NCT00243074 -
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT01126346 -
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
|
N/A | |
Completed |
NCT00039182 -
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
|
Phase 2 | |
Withdrawn |
NCT01325753 -
Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
|
N/A | |
Completed |
NCT00459862 -
Pazopanib in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Active, not recruiting |
NCT01064648 -
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 1/Phase 2 | |
Completed |
NCT00365053 -
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
|
Phase 2 | |
Terminated |
NCT01861301 -
Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
|
Phase 2 | |
Completed |
NCT00392444 -
Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT00309946 -
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT00030498 -
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
|
Phase 1 | |
Recruiting |
NCT03420963 -
Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors
|
Phase 1 |