Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis
Information source: Gachon University Gil Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: Avastin/FOLFIRI (Drug); Curcumin (Dietary Supplement)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Gachon University Gil Medical Center Official(s) and/or principal investigator(s): Jeong-Heum Baek, MD, Ph.D, Principal Investigator, Affiliation: Gachon University Gil Medical Center
Overall contact: Jeong-Heum Baek, MD, Ph.D, Phone: 82-32-460-8428, Email: gsbaek@gilhospital.com
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.
Clinical Details
Official title: First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-free survival
Secondary outcome: Overall survival rateOverall response rate Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0) Quality of life (QoL) Fatigue (FACIT-Fatigue scale (version 4, Korean version)
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jeong-Heum Baek, MD, Ph.D, Phone: 82-32-460-8428, Email: gsbaek@gilhospital.com Additional Information
Starting date: May 2015
Last updated: May 7, 2015
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