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

NCT02439385 | Completed Phase 2 DMC

• 1 other identifier: GAIRB2015-87
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

Curcumin; Avastin; FOLFIRI; Colorectal cancer; Unresectable metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival rate

  3 years

• Overall response rate

  2 years

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

  2 years

• Quality of life (QoL)

  2 years

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

  2 years

Study Arms (1)

Avastin/FOLFIRI with curcumin

EXPERIMENTAL

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

Drug: Avastin/FOLFIRI; Dietary Supplement: Curcumin

Interventions

Avastin/FOLFIRI DRUG

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.

Also known as: Bevacizumab/FOLFIRI

Avastin/FOLFIRI with curcumin

Curcumin DIETARY_SUPPLEMENT

Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily

Avastin/FOLFIRI with curcumin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead
• Aju Pharm: collaborator

Related Publications (1)

• Jeon Y, Sym SJ, Yoo BK, Baek JH. Long-term Survival, Tolerability, and Safety of First-Line Bevacizumab and FOLFIRI in Combination With Ginsenoside-Modified Nanostructured Lipid Carrier Containing Curcumin in Patients With Unresectable Metastatic Colorectal Cancer. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221105498. doi: 10.1177/15347354221105498.

  PMID: 35695002 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Curcumin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Jeong-Heum Baek, MD, Ph.D

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2015
• First Posted: May 8, 2015
• Study Start: August 24, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 31, 2022

Record last verified: 2022-03