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A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients (TAILOR)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228734
First Posted: October 26, 2010
Last Update Posted: July 21, 2017
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.
Information provided by (Responsible Party):
Merck KGaA
  Purpose
The purpose of this study is to assess whether the progression free survival (PFS) time with FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for mCRC in Chinese subjects with RAS wild-type tumors.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: Cetuximab Drug: Oxaliplatin Drug: Folinic Acid Drug: 5Fluorouracil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With RAS Wild-type Status

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Progression Free Survival (PFS) Time [ Time Frame: Baseline up to 246 weeks ]
    PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) Time [ Time Frame: Baseline up to 277 weeks ]
    OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.

  • Best Overall Response Rate (ORR) [ Time Frame: Baseline up to 246 weeks ]
    The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.

  • Time to Treatment Failure (TTF) [ Time Frame: Baseline up to 277 weeks ]
    TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.

  • Number of Subjects With Curative Surgery of Liver Metastases [ Time Frame: Baseline up to 209 weeks ]
    The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.


Enrollment: 553
Actual Study Start Date: September 30, 2010
Estimated Study Completion Date: December 30, 2018
Primary Completion Date: January 25, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab + FOLFOX-4
All eligible subjects will receive cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab will be administered first followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA will be administered and then 5- FU treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: Cetuximab
Cetuximab will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to cetuximab.
Other Names:
  • Erbitux
  • C225
Drug: Oxaliplatin
Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: Folinic Acid
FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: 5Fluorouracil
5-FU as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infusion over 22 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Active Comparator: FOLFOX-4
All eligible subjects will receive FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/ FA. Oxaliplatin will be administered first or simultaneously with FA followed by 5-FU until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: Oxaliplatin
Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: Folinic Acid
FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: 5Fluorouracil
5-FU as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infusion over 22 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.

  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent (first and second)
  • Chinese with Chinese citizenship
  • Male or female subjects greater than or equal to (>=) 18 years of age
  • Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • First occurrence of metastatic disease (not curatively resectable) RAS wild-type status in tumor tissue
  • At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST (not in an irradiated area)
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
  • White blood cell count >= 3 × 10x9/L with neutrophils >= 1.5 × 10x9/L, platelet count >= 100 × 10x9/L and hemoglobin >= 6.21 mmol/L (10 g/dL)
  • Total bilirubin <= 1.5 × upper limit of reference range
  • Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 × upper limit of reference range or <= 5 × upper reference range in subjects with liver metastasis
  • Serum creatinine <= 1.5 × upper limit of reference range
  • Recovery from relevant toxicity due to previous treatment before trial entry

Exclusion Criteria:

  • Previous chemotherapy for CRC except adjuvant treatment if terminated > 9 months (oxaliplatin-based chemotherapy) or > 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial
  • Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before trial treatment
  • Previous treatment with monoclonal antibody therapy, vascular endothelial growth factor (VEGF) pathway-targeting therapy, epidermal growth factor receptor (EGFR) pathway-targeting therapy, or other signal transduction inhibitors
  • History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
  • Renal replacement therapy
  • Intake of any investigational medication within 30 days before trial entry
  • Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement
  • Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry (these growth factors may be used during the trial thereafter)
  • Other non-permitted concomitant anticancer therapies
  • Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
  • Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
  • Active clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis
  • Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Peripheral neuropathy > grade 1
  • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
  • Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure
  • Known hypersensitivity or allergic reactions against any of the components of the trial treatments
  • Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
  • Ongoing alcohol or drug abuse
  • Presence of a medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
  • Participation in another clinical trial within the past 30 days
  • Other significant disease that in the investigator's opinion should exclude the subject from the trial
  • Legal incapacity or limited legal capacity
  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): NCT01228734


Locations
China, Fujian
Fujian Province Cancer Hospital
Fuzhou, Fujian, China, 350014
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
China, Guangdong
First Hospital Affiliated to Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
China, Heilongjiang
The Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150040
China, Hubei
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
First Affiliated Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Shandong
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China, 266003
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
China
307 Hospital of PLA
Beijing, China, 100071
The General Hospital of the People's Liberation Army
Beijing, China, 100853
Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233004
The Xiangya 2nd Hospital of Central South University
Changsha, Hunan, China, 410011
Southwest Hospital
Chongqing, China, 400038
Yunnan Provincial Tumor Hospital
KunMing, Yunnan, China, 650118
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai First People's Hospital
Shanghai, China, 200080
Fudan University Zhongshan Hospital
Shanghai, China
The First Affiliated Hospital of Soochow University
Shuzhou, Jiangsu, China, 215006
Tianjin People's Hospital
Tianjin, China, 30000
Xijing Hospital the 4th Military Medical University of PLA
Xi'an, China, 710032
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck Serono Co., Ltd., Beijing, an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01228734     History of Changes
Other Study ID Numbers: EMR62202-057
First Submitted: September 9, 2010
First Posted: October 26, 2010
Results First Submitted: January 13, 2017
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017
Last Verified: June 2017

Keywords provided by Merck KGaA:
Metastatic colorectal cancer
RAS wild type
Cetuximab
First line treatment
First occurrence of metastatic colorectal cancer in Chinese subjects with RAS wildtype
status

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Cetuximab
Fluorouracil
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances


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