Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer

NCT ID: NCT01993472

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-12-31

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

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Andrographolides with Capecitabine

Capecitabine1250mg/m2 , bid，d1-14，q3w, Andrographolides 500mg，qd，d1-14，q3w;

Group Type: EXPERIMENTAL

Andrographolides

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

Capecitabin alone

Capecitabine1250mg/m2 , bid，d1-14，q3w,

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Interventions

Andrographolides

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

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Other Intervention Names

xiyanpingzhusheye; Xeloda

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gu Yanhong

OTHER

Sponsor Role: lead

Responsible Party

Gu Yanhong

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23202296 (View on PubMed)

Other Identifiers

ANDRO-JSPPH-2013

Identifier Type: OTHER

Identifier Source: secondary_id

AGCRC-013

Identifier Type: -

Identifier Source: org_study_id