Trial | NCT02439385  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    44
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.
Study Started
Aug 24
2015
Primary Completion
Aug 01
2019
Study Completion
Aug 01
2019
Last Update
Mar 31
2022

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

Avastin/FOLFIRI with curcumin Experimental

Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement

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.
No Results Posted