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

First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Avastin/FOLFIRI; Dietary supplement: Curcumin

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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 Names: Bevacizumab/FOLFIRI; Dietary supplement: Curcumin; Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
Overall response rate	According to RECIST criteria v1.1	2 years
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)	2 years
Quality of life (QoL)	QoL measured by the FACT-G (version 4, Korean version)	2 years
Fatigue (FACIT-Fatigue scale (version 4, Korean version)	Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)	2 years

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Collaborators: Aju Pharm
• Investigators: Principal Investigator: Jeong-Heum Baek, MD, Ph.D, Gachon University Gil Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 2, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal cancer; Avastin; Curcumin; FOLFIRI; Unresectable metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Curcumin
• Other Study ID Numbers: GAIRB2015-87