Colorectal Cancer
Conditions
Keywords
Curcumin, Avastin, FOLFIRI, Colorectal cancer, Unresectable metastasis
Brief 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.
Interventions
DRUGAvastin/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.
DIETARY_SUPPLEMENTCurcumin
Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily
Sponsors
Aju Pharm
Gachon University Gil Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 3 years | 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. |
| Overall response rate | 2 years | According to RECIST criteria v1.1 |
| Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0) | 2 years | Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0) |
| Quality of life (QoL) | 2 years | QoL measured by the FACT-G (version 4, Korean version) |
| Fatigue (FACIT-Fatigue scale (version 4, Korean version) | 2 years | Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version) |
Outcome results
None listed