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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Avastin/FOLFIRI
Curcumin
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Avastin/FOLFIRI with curcumin

    Arm Description

    Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement

    Outcomes

    Primary Outcome Measures

    Progression-free survival
    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.

    Secondary Outcome Measures

    Overall survival rate
    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
    According to RECIST criteria v1.1
    Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
    Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
    Quality of life (QoL)
    QoL measured by the FACT-G (version 4, Korean version)
    Fatigue (FACIT-Fatigue scale (version 4, Korean version)
    Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)

    Full Information

    First Posted
    May 2, 2015
    Last Updated
    March 28, 2022
    Sponsor
    Gachon University Gil Medical Center
    Collaborators
    Aju Pharm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02439385
    Brief Title
    Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
    Official Title
    First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 24, 2015 (Actual)
    Primary Completion Date
    August 1, 2019 (Actual)
    Study Completion Date
    August 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gachon University Gil Medical Center
    Collaborators
    Aju Pharm

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Avastin/FOLFIRI with curcumin
    Arm Type
    Experimental
    Arm Description
    Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
    Intervention Type
    Drug
    Intervention Name(s)
    Avastin/FOLFIRI
    Other Intervention Name(s)
    Bevacizumab/FOLFIRI
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Curcumin
    Intervention Description
    Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily
    Primary Outcome Measure Information:
    Title
    Progression-free survival
    Description
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Overall survival rate
    Description
    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.
    Time Frame
    3 years
    Title
    Overall response rate
    Description
    According to RECIST criteria v1.1
    Time Frame
    2 years
    Title
    Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
    Description
    Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
    Time Frame
    2 years
    Title
    Quality of life (QoL)
    Description
    QoL measured by the FACT-G (version 4, Korean version)
    Time Frame
    2 years
    Title
    Fatigue (FACIT-Fatigue scale (version 4, Korean version)
    Description
    Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeong-Heum Baek, MD, Ph.D
    Organizational Affiliation
    Gachon University Gil Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35695002
    Citation
    Jeon Y, Sym SJ, Yoo BK, Baek JH. Long-term Survival, Tolerability, and Safety of First-Line Bevacizumab and FOLFIRI in Combination With Ginsenoside-Modified Nanostructured Lipid Carrier Containing Curcumin in Patients With Unresectable Metastatic Colorectal Cancer. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221105498. doi: 10.1177/15347354221105498.
    Results Reference
    derived

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

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