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Robert A Ramirez
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EP1.12 - Small Cell Lung Cancer/NET (ID 202)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.12-18 - NET-001: A Phase II Study of ABI-009 in Metastatic Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System (Now Available) (ID 1391)
08:00 - 18:00 | Presenting Author(s): Robert A Ramirez
- Abstract
Background
Neuroendocrine tumors (NETs) are a heterogeneous group of malignancies with limited systemic treatment options. Preclinical evidence has shown that the PI3K/AKT/mTOR signaling pathway plays a central role in the pathogenesis and progression of NETs. Clinical studies with the mTOR inhibitor, everolimus, demonstrated its safety and efficacy in the treatment of NET, however, patients will ultimately progress. A novel mTOR inhibitor, ABI-009 (albumin-bound rapamycin nanoparticles, nab-rapamycin), has a favorable safety profile and evidence of efficacy in patients with solid tumors and offers promise for NETs. A preclinical study showed significantly greater antitumor activity and prolonged survival with ABI-009 compared with equal weekly dosing of oral rapamycin and oral everolimus. This preclinical study demonstrated superior efficacy of ABI-009 to oral mTOR inhibitors and suggest that ABI-009 may result in disease control after everolimus failure. The goal of this phase II pilot study is to evaluate the utility of ABI-009 in NETs to warrant a full phase II clinical study.
Method
This pilot phase II trial is a prospective, open-label, single arm, single center trial evaluating the efficacy and safety of ABI-009 in patients with gastroenteropancreatic or lung NETs who have undergone prior treatment with everolimus. Patients with unresectable, metastatic grade 1 and 2 NETs of the gastroenteropancreatic system or lung who have progressed or have been intolerant to everolimus will be eligible for inclusion in this study. The study will enroll 10 patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. ABI-009 will be administered intravenously at 100 mg/m2 on days 1 and 8 of a 21-day cycle. Patients will be treated until disease progression. Tumor response will be assessed by computerized tomography scan at baseline then every 9 weeks for 1 year, then every 12 weeks thereafter until progression. The primary endpoint is disease control rate at 6 months measured by RECIST 1.1. Currently, 3 of the planned 10 patients have been enrolled. ClinicalTrials.gov Identifier: NCT03670030.
Result
Section not applicable
Conclusion
Section not applicable
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P2.12 - Small Cell Lung Cancer/NET (ID 180)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.12-05 - A Phase II Trial of Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Neuroendocrine Carcinoma (Now Available) (ID 1429)
10:15 - 18:15 | Presenting Author(s): Robert A Ramirez
- Abstract
Background
Combination chemotherapy is the mainstay of treatment for patients with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEPNECs) and neuroendocrine carcinomas (NECs) of the lung. Pembrolizumab, a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb), has high specificity for binding to the programmed cell death 1 (PD-1) receptor thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). In combination with chemotherapy, pembrolizumab blocks the protective mechanism of cancer cells and allows the immune system to destroy them. Combination chemotherapy and pembrolizumab was recently FDA approved and ongoing trials are utilizing this or similar combinations with data demonstrating a promising safety profile. The purpose of this study is to test the efficacy, safety, and tolerability of combination chemotherapy with pembrolizumab in patients with high-grade neuroendocrine carcinomas of the gastroenteropancreatic system or lung who are chemotherapy naïve.
Method
This is an open label, phase II, single institution, multi-site trial using pembrolizumab in combination with either cisplatin or carboplatin and etoposide in patients with high grade neuroendocrine carcinomas of the gastroenteropancreatic system or lung who are chemotherapy naïve. Patients with a histologic diagnosis of a GEPNECs with a Ki-67 of 55% or higher or a large cell NEC of the lung will be eligible for inclusion in this study. Subjects must be deemed unresectable and have not undergone prior chemotherapy for metastatic disease. Patients must also have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1, and a predicted life expectancy > 3 months.
Approximately 36 GEPNEC patients will be enrolled with an exploratory LCNEC of the lung cohort of approximately 6 patients. Patients will receive pembrolizumab 200mg IV in combination with cisplatin 80 mg/m2 or carboplatin AUC 6 on day 1 and etoposide 100mg/m2 on days 1-3 of a 21-day cycle. Tumor response will be assessed by computerized tomography scan every 6 weeks calculated with the first CT within 7 days of initiation of treatment. RECIST 1.1 will be used for treatment decisions until there is evidence of progressive disease (PD). Those patients who have responsive or stable disease after 4-6 cycles of platinum-based chemotherapy will move to maintenance pembrolizumab every 3 weeks. The primary endpoint will be progression free survival (PFS) per RECIST 1.1. ClinicalTrials.gov Identifier: NCT03901378
Result
Section not applicable
Conclusion
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