Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer (AGCRC-013)
Primary Purpose
Colorectal Neoplasms
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Andrographolides
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
- Locally advanced or recurrent or metastasis inoperable disease
- 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.
- Man or woman ≥ 65 years of age
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
Renal function, as follows: (≤ 10 days prior to randomization)
- Creatinine≤ 1.5×ULN
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
- Subject or subject's legally acceptable representative has provided informed consent
Exclusion Criteria:
- Symptomatic brain metastases requiring treatment
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
- Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity
- Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization
- History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI
- 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
- 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.
- 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
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Andrographolides with Capecitabine
Capecitabin alone
Arm Description
Capecitabine1250mg/m2 , bid,d1-14,q3w, Andrographolides 500mg,qd,d1-14,q3w;
Capecitabine1250mg/m2 , bid,d1-14,q3w,
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
Secondary Outcome Measures
overall survival
Response Rate
Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01993472
Brief Title
Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer
Acronym
AGCRC-013
Official Title
Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
low accrual rate
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gu Yanhong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Andrographolides with Capecitabine
Arm Type
Experimental
Arm Description
Capecitabine1250mg/m2 , bid,d1-14,q3w, Andrographolides 500mg,qd,d1-14,q3w;
Arm Title
Capecitabin alone
Arm Type
Active Comparator
Arm Description
Capecitabine1250mg/m2 , bid,d1-14,q3w,
Intervention Type
Drug
Intervention Name(s)
Andrographolides
Other Intervention Name(s)
xiyanpingzhusheye
Intervention Description
comparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
From date of randomization until the date of first documented progression,assessed up to 100 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
From date of randomization until the date of death from any cause,assessed up to 100 months
Title
Response Rate
Time Frame
From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months
Title
Quality of Life
Time Frame
From date of randomization until the date of death from any cause,assessed up to 100 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
Locally advanced or recurrent or metastasis inoperable disease
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.
Man or woman ≥ 65 years of age
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
Renal function, as follows: (≤ 10 days prior to randomization)
Creatinine≤ 1.5×ULN
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
Subject or subject's legally acceptable representative has provided informed consent
Exclusion Criteria:
Symptomatic brain metastases requiring treatment
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
Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity
Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization
History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI
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
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.
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
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23202296
Citation
Bruchard M, Mignot G, Derangere V, Chalmin F, Chevriaux A, Vegran F, Boireau W, Simon B, Ryffel B, Connat JL, Kanellopoulos J, Martin F, Rebe C, Apetoh L, Ghiringhelli F. Chemotherapy-triggered cathepsin B release in myeloid-derived suppressor cells activates the Nlrp3 inflammasome and promotes tumor growth. Nat Med. 2013 Jan;19(1):57-64. doi: 10.1038/nm.2999. Epub 2012 Dec 2.
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Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer
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