Study of Cetuximab in Combination With mFOLFOX-6 (Oxaliplatin, Leucovorin, 5-FU) to Treat Colorectal Liver Metastatic Cancer Patients

NCT01322178 | Unknown Phase 2 DMC

• 1 other identifier: EMR 62202-203
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore whether cetuximab in combination with mFOLFOX6 as treatment could improve the resection rate in patients with KRAS wild-type, unresectable liver metastases of mCRC.

Conditions

Colorectal Cancer; Liver Metastases

Keywords

cetuximab; colorectal carcinoma

Outcome Measures

Primary Outcomes (1)

• Resection rate (R0)

  from the first cycle of treatment (day one) to two month after the last cycle

Secondary Outcomes (2)

• Response rate,Progression-free Survival,Overall Survival,R1 resection rate

  from the first cycle of treatment (day one) to six month after the last cycle

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  from the first cycle of treatment (day one) to six month after the last cycle

Interventions

Cetuximab; mFOLFOX6 DRUG

Cetuximab (Erbitux): 500 mg/m2 iv gtt, D1 Oxaliplatin: 85 mg/m2 iv gtt over 2 hours, D1; leucovorin: 400 mg/m2 iv gtt , D1; 5-FU: 400 mg/m2 iv, 2400 mg/m2 civ46h repeated every two weeks for 4.5 months(9 cycles)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18-75 years of age
• Performance status (ECOG) 0\~1
• Unresectable, histologically confirmed, synchronous or metachronous liver metastasis of colorectal cancer. Unresectable liver metastases is defined as:
• patients with five and more liver metastases and/or
• Liver metastases that are technically unresectable immediately, and expected remaining functional liver tissue ≥ 30% after resection. (Patients should be evaluated by a multidisciplinary team of three local surgeons and one local radiologist, including surgical consultation for potentially resectable patients on the basis of remaining liver volume, infiltration of all liver veins, infiltration of both liver arteries, both portal branches or both bile ducts.)
• Tumor tissue (primary or metastasis) genotypologically classified as KRAS wild-type in codon 12 and codon 13 of the KRAS gene exon 2
• No prior chemotherapy (except adjuvant chemotherapy with an interval of ≥ 6 months)
• Presence of at least one index lesion of hepatic metastasis measurable by CT scan or MRI, not in an irradiated area
• Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL
• Bilirubin level ≤ 1.0 x ULN
• AST and ALT \< 1.5 x ULN
• Serum creatinine ≤ 1.0 x ULN
• Life expectancy of ≥ 3 months
• Male or female of child-bearing period should have effective contraception
• Signed written informed consent

You may not qualify if:

• Any investigational agent(s) within 4 weeks prior to entry
• Previous exposure to EGFR-targeting therapy
• Any evidence of extrahepatic metastases and/or primary tumor recurrence
• Total volumes of liver lesions \> 70%
• Clinically relevant peripheral neuropathy
• Acute or sub-acute intestinal obstruction or history of inflammatory bowel disease
• Breast-feeding or pregnant women, no effective contraception if risk of conception exists (for male and female patients up to 4 months after end of chemotherapy)
• Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
• Known drug abuse/ alcohol abuse
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

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

Study Officials

• Sanjun Cai, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjun Cai, phD

CONTACT

8621-64175590; caisanjun@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2013
• Last Updated: August 12, 2011

Record last verified: 2011-08

Locations

CN (1)