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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Avastin/FOLFIRI
* Dietary Supplement: Curcumin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avastin/FOLFIRI with curcumin<br>Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement | Drug: Avastin/FOLFIRI<br>* 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.<br>* Other names: Bevacizumab/FOLFIRI;Dietary Supplement: Curcumin<br>* Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall response rate | According to RECIST criteria v1.1 | 2 years | 
| 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 | 
| Quality of life (QoL) | QoL measured by the FACT-G (version 4, Korean version) | 2 years | 
| Fatigue (FACIT-Fatigue scale (version 4, Korean version) | Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis