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Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis

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: NCT02439385
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Aju Pharm
Information provided by (Responsible Party):
Jeong-Heum Baek, MD, Gachon University Gil Medical Center

Tracking Information
First Submitted Date  ICMJE May 2, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date February 19, 2019
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Progression-free survival [ Time Frame: 2 years ]
The primary end point of this study is to evaluate progression-free survival in colorectal cancer patients with unresectable metastasis after treatment with first line Avastin/FOLFIRI in combination with a dietary supplement of nanostructured lipid curcumin particle (Aju Pharm, Korea), which improved biotransformation and bioavailability profiles of curcumin.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02439385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2019)
  • Overall survival rate [ Time Frame: 3 years ]
    Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months.
  • Overall response rate [ Time Frame: 2 years ]
    According to RECIST criteria v1.1
  • Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0) [ Time Frame: 2 years ]
    Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
  • Quality of life (QoL) [ Time Frame: 2 years ]
    QoL measured by the FACT-G (version 4, Korean version)
  • Fatigue (FACIT-Fatigue scale (version 4, Korean version) [ Time Frame: 2 years ]
    Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Overall survival rate [ Time Frame: 3 years ]
  • Overall response rate [ Time Frame: 2 years ]
  • Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0) [ Time Frame: 2 years ]
    Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
  • Quality of life (QoL) [ Time Frame: 2 years ]
    QoL measured by the FACT-G (version 4, Korean version)
  • Fatigue (FACIT-Fatigue scale (version 4, Korean version) [ Time Frame: 2 years ]
    Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
Official Title  ICMJE First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
Brief Summary Oral curcumin-containing supplement will be given to colorectal cancer patients with unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to completion of (or withdrawal from) chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Avastin/FOLFIRI
    Avastin: 5mg/kg iv on day1, every 14 days. Irinotecan: 180 mg /m2 iv on day1, every 14 days. Leucovorin: 200 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil bolus: 400 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil infusion: 1200 mg/m2 iv on day1,2 every 14 days.
    Other Name: Bevacizumab/FOLFIRI
  • Dietary Supplement: Curcumin
    Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily
Study Arms  ICMJE Experimental: Avastin/FOLFIRI with curcumin
Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
Interventions:
  • Drug: Avastin/FOLFIRI
  • Dietary Supplement: Curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
44
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age : 20 Years and older
  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Patients with primary colon or rectal cancer and unresectable metastatic lesions.
  • Patients with no primary cancer related symptoms.
  • ECOG performance status of 0 - 2
  • Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
  • ASA score of < 3
  • An informed consent form has been signed by the patient.

Exclusion Criteria:

  • Colorectal cancer other than adenocarcinoma
  • The patient received adjuvant chemotherapy within the past 6 months.
  • The patient received chemotherapy for metastatic colon cancer.
  • The patient was planning to have curative surgery for the metastatic lesions.
  • Patients with peritoneal carcinomatosis.
  • Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
  • ASA score of > 4
  • The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
  • Patients with an active infection, which need antibiotic therapy, during the randomization period.
  • Pregnant or breastfeeding women
  • Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439385
Other Study ID Numbers  ICMJE GAIRB2015-87
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeong-Heum Baek, MD, Gachon University Gil Medical Center
Study Sponsor  ICMJE Gachon University Gil Medical Center
Collaborators  ICMJE Aju Pharm
Investigators  ICMJE
Principal Investigator: Jeong-Heum Baek, MD, Ph.D Gachon University Gil Medical Center
PRS Account Gachon University Gil Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP