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

Sponsor

Gachon University Gil Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02439385

Collaborator

Aju Pharm (Other)

Enrollment

Arm

47.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Avastin/FOLFIRI Dietary Supplement: Curcumin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 24, 2015

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progression-free survival [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.

Secondary Outcome Measures

Overall survival rate [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 [2 years]
According to RECIST criteria v1.1
Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0) [2 years]
Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Quality of life (QoL) [2 years]
QoL measured by the FACT-G (version 4, Korean version)
Fatigue (FACIT-Fatigue scale (version 4, Korean version) [2 years]
Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.