Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery
|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||Drug: cyclodextrin-based polymer-camptothecin CRLX101 Other: Laboratory biomarker analysis Other: Pharmacological studies|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Pilot Trial of CRLX101 in the Treatment of Patients With Advanced Gastric, Gastroesophageal, or Esophageal Squamous or Adenocarcinoma|
- Change in CRLX101 uptake in tumor and nearby normal tissue [ Time Frame: Baseline and day 8 ]The effect size is the mean difference divided by the standard deviation of the difference.
- Response (Complete Response + Partial Response) assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 4 years ]
- Clinical benefit (Complete Response + Partial Response + Stable Disease) [ Time Frame: At least 4 months post treatment, assessed up to 4 years ]
- Overall survival [ Time Frame: From date of start of therapy to date of death due to any cause, assessed up to 4 years ]
- Incidence of adverse events [ Time Frame: Up to 4 years ]
|Study Start Date:||November 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cyclodextrin-based polymer-camptothecin CRLX101)
Patients receive cyclodextrin-based polymer-camptothecin CRLX101 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. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.
Drug: cyclodextrin-based polymer-camptothecin CRLX101
Other Names:Other: Laboratory biomarker analysis
Correlative studiesOther: Pharmacological studies
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612546
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Joseph Chao||City of Hope Medical Center|