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
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis
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.
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
NCT ID
NCT02439385
First Posted
May 2, 2015
Last Updated
March 28, 2022
Sponsor
Gachon University Gil Medical Center
Collaborators
Aju Pharm
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
Learn more about this trial
Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
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