Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer (AGCRC-013)

January 12, 2020 updated by: Gu Yanhong

Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial.

The purpose of this study is to determine the efficacy and safety of Andrographolides combined with Capecitabine in treatment of elderly patients with locally advanced or recurrent or metastasis inoperable colorectal cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

308

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
  2. Locally advanced or recurrent or metastasis inoperable disease
  3. At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization.
  4. Man or woman ≥ 65 years of age

  5. Hematological function, as follow: (≤ 10 days prior to randomization)

    • Absolute neutrophil count (ANC) ≥ 1.5×109/L
    • Platelet count ≥ 75×109/L
    • Hemoglobin ≥ 8.0 g/dL

  6. Renal function, as follows: (≤ 10 days prior to randomization)

    • Creatinine≤ 1.5×ULN

  7. Hepatic function, as follow: (≤ 10 days prior to randomization)

    • Aspartate aminotransferase (AST) ≤ 3×ULN(if liver metastases≤ 5×ULN )
    • Alanine aminotransferase (ALT) ≤ 3×ULN(if liver metastases≤ 5×ULN )
    • Total bilirubin≤ 1.5×ULN
  8. Subject or subject's legally acceptable representative has provided informed consent

Exclusion Criteria:

  1. Symptomatic brain metastases requiring treatment

  2. History of other malignancy, except:

    • Malignancy treated with curative intent and with no known active disease present for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician
    • Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
    • Adequately treated cervical carcinoma in situ without evidence of disease
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer
  3. Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity
  4. Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
  5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization
  6. History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI
  7. History of any medical or psychiatric condition or labortory abnomality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results
  8. Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤ 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to rangdomization.
  9. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Andrographolides with Capecitabine
Capecitabine1250mg/m2 , bid，d1-14，q3w, Andrographolides 500mg，qd，d1-14，q3w;
Drug: Capecitabine
Other Names:
  • Xeloda
Drug: Andrographolides
comparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer
Other Names:
  • xiyanpingzhusheye
Active Comparator: Capecitabin alone
Capecitabine1250mg/m2 , bid，d1-14，q3w,
Drug: Capecitabine
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: From date of randomization until the date of first documented progression，assessed up to 100 months
From date of randomization until the date of first documented progression，assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: From date of randomization until the date of death from any cause，assessed up to 100 months
From date of randomization until the date of death from any cause，assessed up to 100 months
Response Rate
Time Frame: From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months
From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months
Quality of Life
Time Frame: From date of randomization until the date of death from any cause，assessed up to 100 months
From date of randomization until the date of death from any cause，assessed up to 100 months

Collaborators and Investigators

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

Sponsor

Gu Yanhong

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

November 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGCRC-013
  • ANDRO-JSPPH-2013 (Other Identifier: Jiangsu Province People's Hospital)

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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