Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer

Colorectal Neoplasms Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01993472
• Other study ID #: AGCRC-013
• Secondary ID: ANDRO-JSPPH-2013
• Status: Terminated
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 308
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Andrographolides
comparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer
• Capecitabine

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Gu Yanhong

Country where clinical trial is conducted

China, 

References & Publications (1)

Bruchard M, Mignot G, Derangère V, Chalmin F, Chevriaux A, Végran F, Boireau W, Simon B, Ryffel B, Connat JL, Kanellopoulos J, Martin F, Rébé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		From date of randomization until the date of first documented progression,assessed up to 100 months
Secondary	overall survival		From date of randomization until the date of death from any cause,assessed up to 100 months
Secondary	Response Rate		From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months
Secondary	Quality of Life		From date of randomization until the date of death from any cause,assessed up to 100 months