Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT01612546|
Recruitment Status : Completed
First Posted : June 6, 2012
Results First Posted : December 27, 2017
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of CRLX101 in the Treatment of Patients With Advanced Gastric, Gastroesophageal, or Esophageal Squamous or Adenocarcinoma|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||January 15, 2015|
|Actual Study Completion Date :||January 15, 2015|
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: Laboratory biomarker analysis
Other: Pharmacological studies
- CRLX101 (CPT) Uptake in Tumor and Nearby Normal Tissue [ Time Frame: Baseline and day 8 ]Using Fisher's Exact to determine statistical significance in detection of a CPT fluorescence signal posttreatment between tumor and adjacent normal tissue biopsy specimens.
- Overall Objective Response Rate [ Time Frame: Up to 4 years ]Patients with best response of Complete Response or Partial Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Clinical Benefit Rate [ Time Frame: At least 4 months post treatment, assessed up to 4 years ]Patients with a best response of Complete Response, Partial Response or Stable Disease after at least 4 months of treatment assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), not a CR, PR, Progression or Symptomatic Deterioration; Progression (PD), a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Symptomatic Deterioration, global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Clinical Benefit (CR + PR +SD≥4months).
- Overall Survival [ Time Frame: From date of start of therapy to date of death due to any cause, assessed up to 4 years ]Estimated using the product-limit method of Kaplan and Meier.
- Incidence of Adverse Events [ Time Frame: Up to 4 years ]Incidence of treatment related adverse events graded per NCI CTCAE version 4.03
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612546
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Joseph Chao||City of Hope Medical Center|