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

Gu Yanhong

Status and phase: Terminated; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: Capecitabine; Drug: Andrographolides

Study type: Interventional

Funder types: Other

Identifiers

NCT01993472

AGCRC-013

ANDRO-JSPPH-2013 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 308 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Andrographolides with Capecitabine

Experimental group

Description:

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

Treatment:

Drug: Andrographolides

Drug: Capecitabine

Capecitabin alone

Active Comparator group

Description:

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

Treatment:

Drug: Capecitabine