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OpenTrials
Completed

NCT Number: NCT02439385

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bevacizumab/FOLFIRI

Curcumin

Dietary Supplement

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

Primary outcomes

  1. 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 outcomes

  1. Overall survival rate

    Time frame: 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.

  2. Overall response rate

    Time frame: 2 years

    According to RECIST criteria v1.1

  3. 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)

  4. Quality of life (QoL)

    Time frame: 2 years

    QoL measured by the FACT-G (version 4, Korean version)

  5. Fatigue (FACIT-Fatigue scale (version 4, Korean version)

    Time frame: 2 years

    Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Collaborators

  • Aju Pharm

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 8, 2015
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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