Apatinib for Metastatic Esophageal Cancer.

August 25, 2016 updated by: Shixiu Wu, Hangzhou Cancer Hospital

A Phase II Study of Apatinib for Patients With Heavily Pretreated, Metastatic Esophageal Cancer.

Patients with esophageal cancer that had metastatic lesions after been treated with surgery or definitive chemoradiotherapy are being asked to participate in this study.

Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.

The purpose of this study is to determine what effects apatinib has on metastatic esophageal cancer. These effects include whether apatinib could shrink the tumor or slow down its growth and what side effects apatinib will have on the tumor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine what effects apatinib has on metastatic esophageal cancer patients after been treated with surgery or definitive chemoradiotherapy. These effects include whether apatinib could shrink the tumor or slow down its growth and what side effects apatinib will have on the tumor.

Eligible are patients with metastatic esophageal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least one separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded either at CT or MRI scanning. Apatinib (850mg) is given daily during the therapy for 28 days. Tumor response is evaluated by assessing clinical and CT/MRI response in the metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no tumor responses, the trial will be terminated. If there are one or more responses in Stage One, the trial will proceed to enroll an additional 19 patients.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with histologically confirmed esophageal cancer which is persistent and metastatic or recurrent and metastatic;
  2. Patients must have distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;
  3. Age ≥18 years;
  4. Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
  5. ECOG performance status: 0-1;
  6. Life expectancy ≥ 3 months.
  7. Patients have adequate baseline organ and marrow function as defined by an absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
  8. Signed consent forms voluntarily;

Exclusion Criteria:

  1. Patients who have had prior allergic reaction to Apatinib;
  2. Patients undergoing therapy with other investigational agents.
  3. Women who are pregnant or breastfeeding;
  4. Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;
  5. Anticipated patient survival under 3 months;
  6. Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus;
  7. Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive heart failure within the last 6 months;
  8. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
  9. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
  10. Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib arm
Patients with metastatic lesions of esophageal cancer after been treated with surgery or definitive chemoradiotherapy receiving Apatinib (850mg) daily over 4 weeks.
Drug: Apatinib
Patients with metastatic lesions of esophageal cancer after been treated with surgery or definitive chemoradiotherapy receiving Apatinib (850mg) daily over 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with response (CR, PR, SD and PD based on RECIST version 1.0) assessed at 5-6 weeks after the initiation of treatment.
Time Frame: week 5- week 6
week 5- week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.
Time Frame: year 0- year 2
year 0- year 2
The proportion of patients alive (overall survival rate) from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.
Time Frame: year 0- year 2
year 0- year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 6, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HangzhouCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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