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

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. Identifier: NCT01322178
Recruitment Status : Unknown
Verified August 2011 by Fudan University.
Recruitment status was:  Recruiting
First Posted : March 24, 2011
Last Update Posted : August 12, 2011
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Drug: Cetuximab; mFOLFOX6 Phase 2

Detailed Description:

During the last decade, chemotherapy in metastatic colorectal cancer (mCRC) has made considerable progress.However, approximately 25% of patients with colorectal cancer present with overt metastatic disease. In selected patients, synchronous or metachronous liver metastases (LM) can be resected in curative intention. Over the last 5 years there has been the recognition that preoperative, neoadjuvant, combination chemotherapy regimens, namely, 5-fluorouracil/folinic acid (5-FU/FA) in combination with either irinotecan or oxaliplatin can facilitate to downsize the initially unresectable LM and make the resection possible. The addition of targeted therapies might render them even more effective.

Due to these results, the investigators hypothesize that cetuximab in combination with mFOLFOX6 as treatment in patients with KRAS wild-type, unresectable liver metastases of mCRC may further improve clinical outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Uncontrolled, Multi-center, Phase II Study of Cetuximab in Combination With mFOLFOX-6 as First-line Treatment in Patients With KRAS Wild-type, Unresectable LIver Metastases of colorEctal Cancer
Study Start Date : December 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Intervention Details:
  • Drug: Cetuximab; mFOLFOX6

    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)

Primary Outcome Measures :
  1. Resection rate (R0) [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

Secondary Outcome Measures :
  1. Response rate,Progression-free Survival,Overall Survival,R1 resection rate [ Time Frame: from the first cycle of treatment (day one) to six month after the last cycle ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: from the first cycle of treatment (day one) to six month after the last cycle ]

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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT01322178

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Contact: Sanjun Cai, phD 8621-64175590

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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Wenhua Li, MD    8621-64175590   
Sponsors and Collaborators
Fudan University
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Principal Investigator: Sanjun Cai, PhD Fudan University
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Responsible Party: Sanjun Cai, Fudan University Shanghai Cancer Center Identifier: NCT01322178    
Other Study ID Numbers: EMR 62202-203
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Keywords provided by Fudan University:
colorectal carcinoma
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Immunological
Antineoplastic Agents