Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 435 for:    colon cancer AND Capecitabine AND colon cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993472
Recruitment Status : Unknown
Verified November 2013 by Gu Yanhong, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Gu Yanhong, The First Affiliated Hospital with Nanjing Medical University

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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Andrographolides Drug: Capecitabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Andrographolides with Capecitabine
Capecitabine1250mg/m2 , bid,d1-14,q3w, Andrographolides 500mg,qd,d1-14,q3w;
Drug: Andrographolides
comparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer
Other Name: xiyanpingzhusheye

Drug: Capecitabine
Other Name: Xeloda

Active Comparator: Capecitabin alone
Capecitabine1250mg/m2 , bid,d1-14,q3w,
Drug: Capecitabine
Other Name: Xeloda




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression,assessed up to 100 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 100 months ]
  2. Response Rate [ Time Frame: From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months ]
  3. Quality of Life [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 100 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993472


Contacts
Layout table for location contacts
Contact: Yanhong Gu, Ph.D 008613813908678 oncotar@163.com

Locations
Layout table for location information
China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yanhong Gu, Ph.D    13813908678    oncotar@163.com   
Principal Investigator: Yanhong Gu, Ph.D         
Principal Investigator: Yongqian Shu, Ph.D         
Sponsors and Collaborators
Gu Yanhong

Publications:
Layout table for additonal information
Responsible Party: Gu Yanhong, Director, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01993472     History of Changes
Other Study ID Numbers: AGCRC-013
ANDRO-JSPPH-2013 ( Other Identifier: Jiangsu Province People's Hospital )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Andrographolide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors