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

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Collaborator: Aju Pharm
• Treatments: Bevacizumab; Curcumin

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.