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

Gachon University Gil Medical Center

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Avastin/FOLFIRI

Dietary Supplement: Curcumin

Study type

Interventional

Funder types

Other

Identifiers

NCT02439385

GAIRB2015-87

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

20+ years old

Volunteers

No 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.