NCT02317991

Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer

Phase II Study of Nab-Paclitaxel and Ramucirumab for the Second-line Treatment of Patients With Metastatic Gastroesophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy.

Detailed description

Adenocarcinoma of the esophagus and the gastroesophageal junction (GE junction) is the ninth most common cancer worldwide. Ramucirumab (Cyramza®), a monoclonal antibody, is approved as a single agent and in combination with paclitaxel as a treatment for patients with metastatic gastric or GE junction adenocarcinoma whose cancer has progressed after prior chemotherapy. Nab-paclitaxel (Abraxane®) is an albumin-based formulation of paclitaxel which was developed to improve the therapeutic index and reduce toxicity. Nab-paclitaxel is approved in over 40 countries/regions for treatment of various metastatic cancers including breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. In this Phase II study, the investigators propose to combine the less toxic nab-paclitaxel to increase tumor uptake of the drug and improve efficacy while minimizing side effects. The biological rationale of using this combination is that ramucirumab will inhibit tumor angiogenesis and nab-paclitaxel will induce apoptosis of the rapidly dividing tumor cell.

Conditions

• Gastroesophageal Cancer

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	nab-paclitaxel 125 mg/m\^2 IV
BIOLOGICAL	ramucirumab	Ramucirumab 8 mg/kg IV

Timeline

• Start date: 2015-05-05
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2014-12-17
• Last updated: 2022-07-01
• Results posted: 2022-07-01

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study