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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439385
• Other study ID #: GAIRB2015-87
• Status: Completed
• Phase: Phase 2
• Start date: August 24, 2015
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2022
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

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.

Dietary Supplement:
• Curcumin
Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Aju Pharm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall response rate	According to RECIST criteria v1.1	2 years
Secondary	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
Secondary	Quality of life (QoL)	QoL measured by the FACT-G (version 4, Korean version)	2 years
Secondary	Fatigue (FACIT-Fatigue scale (version 4, Korean version)	Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)	2 years