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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02439385
First Posted: May 8, 2015
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aju Pharm
Information provided by (Responsible Party):
Jeong-Heum Baek, MD, Gachon University Gil Medical Center
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer Drug: Avastin/FOLFIRI Dietary Supplement: Curcumin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis

Resource links provided by NLM:


Further study details as provided by Jeong-Heum Baek, MD, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 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 Outcome Measures:
  • Overall survival rate [ Time Frame: 3 years ]
  • Overall response rate [ Time Frame: 2 years ]
  • Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0) [ Time Frame: 2 years ]
    Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)

  • Quality of life (QoL) [ Time Frame: 2 years ]
    QoL measured by the FACT-G (version 4, Korean version)

  • Fatigue (FACIT-Fatigue scale (version 4, Korean version) [ Time Frame: 2 years ]
    Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)


Estimated Enrollment: 44
Study Start Date: August 2015
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin/FOLFIRI with curcumin
Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
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 Name: Bevacizumab/FOLFIRI
Dietary Supplement: Curcumin
Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439385


Sponsors and Collaborators
Gachon University Gil Medical Center
Aju Pharm
Investigators
Principal Investigator: Jeong-Heum Baek, MD, Ph.D Gachon University Gil Medical Center
  More Information

Responsible Party: Jeong-Heum Baek, MD, Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02439385     History of Changes
Other Study ID Numbers: GAIRB2015-87
First Submitted: May 2, 2015
First Posted: May 8, 2015
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by Jeong-Heum Baek, MD, Gachon University Gil Medical Center:
Curcumin
Avastin
FOLFIRI
Colorectal cancer
Unresectable metastasis

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Curcumin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors