NCT01612546

Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery

Pilot Trial of CRLX101 in the Treatment of Patients With Advanced Gastric, Gastroesophageal, or Esophageal Squamous or Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has progressed through at least one prior regimen of chemotherapy and cannot be removed by surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor cells and is hypothesized to interrupt the growth of tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate pre- and post-treatment biopsies to assess CRLX101 (cyclodextrin-based polymer-camptothecin CRLX101) nanoparticle and 20(S)-Camptothecin (CPT) uptake in tumor and normal tissue. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity of CRLX101 in this patient population. II. To examine the antitumor efficacy of CRLX101 in advanced gastric/gastroesophageal junction (GEJ)/esophageal squamous or adenocarcinoma including clinical benefit rate (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) at 4 months and overall survival. OUTLINE: Patients receive cyclodextrin-based polymer-camptothecin CRLX101 intravenously (IV) over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better, may receive treatment for an additional 6 months. After completion of study treatment, patients are followed up monthly.

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Diffuse Adenocarcinoma of the Stomach
• Intestinal Adenocarcinoma of the Stomach
• Mixed Adenocarcinoma of the Stomach
• Recurrent Esophageal Cancer
• Recurrent Gastric Cancer
• Squamous Cell Carcinoma of the Esophagus
• Stage IIIB Esophageal Cancer
• Stage IIIB Gastric Cancer
• Stage IIIC Esophageal Cancer
• Stage IIIC Gastric Cancer
• Stage IV Esophageal Cancer
• Stage IV Gastric Cancer

Interventions

Type	Name	Description
DRUG	cyclodextrin-based polymer-camptothecin CRLX101	Given IV
OTHER	Laboratory biomarker analysis	Correlative studies
OTHER	Pharmacological studies	Correlative studies

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-01-15
• Completion: 2015-01-15
• First posted: 2012-06-06
• Last updated: 2018-02-01
• Results posted: 2017-12-27

Locations

1 site across 1 country: United States