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

Information source: Gachon University Gil Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: Avastin/FOLFIRI (Drug); Curcumin (Dietary Supplement)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Gachon University Gil Medical Center

Official(s) and/or principal investigator(s):
Jeong-Heum Baek, MD, Ph.D, Principal Investigator, Affiliation: Gachon University Gil Medical Center

Overall contact:
Jeong-Heum Baek, MD, Ph.D, Phone: 82-32-460-8428, Email: gsbaek@gilhospital.com


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome:

Overall survival rate

Overall response rate

Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)

Quality of life (QoL)

Fatigue (FACIT-Fatigue scale (version 4, Korean version)


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Jeong-Heum Baek, MD, Ph.D, Phone: 82-32-460-8428, Email: gsbaek@gilhospital.com

Additional Information

Starting date: May 2015
Last updated: May 7, 2015

Page last updated: August 20, 2015

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