Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer (NCT01993472) | Clinical Trial Compass
TerminatedPhase 2
Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer
Stopped: low accrual rate
China308 participantsStarted 2013-11
Plain-language 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
Who can participate
Age range65 Years
SexALL
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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)
✓. Renal function, as follows: (≤ 10 days prior to randomization)
✓. Hepatic function, as follow: (≤ 10 days prior to randomization)
✓. Subject or subject's legally acceptable representative has provided informed consent
✕. 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
What they're measuring
1
Progression free survival (PFS)
Timeframe: From date of randomization until the date of first documented progression，assessed up to 100 months
✕. 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.