Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
Study of Cetuximab in Combination With Chemotherapy for the First Treatment of Metastatic Colorectal Cancer
1 other identifier
interventional
150
1 country
1
Brief Summary
In this study, the investigators assessed the effect of Cetuximab in combination with chemotherapy in the treatment of unresectable metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 24, 2012
October 1, 2012
5.8 years
March 26, 2012
October 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the rate of patients converted to resection for liver metastases
To explore whether cetuximab in combination with chemotherapy as treatment could improve the resection rate in patients with KRAS wild-type, unresectable colorectal liver-limited metastases compared with chemotherapy alone.
3 years
Secondary Outcomes (3)
progression free survival
3 years
overall survival
3 years
tumor response
3 years
Study Arms (2)
Arm A
EXPERIMENTALpatients received cetuximab in combination with chemotherapy
Arm B
ACTIVE COMPARATORPatients received chemotherapy (mFOLFOX6 or FOLFIRI) alone. mFOLFOX6 (day 1, oxaliplatin 85 mg/m², folinic acid 400 mg/m², and fluorouracil 400 mg/m² intravenous bolus, then 2400 mg/m² over 46 h continuous infusion) FOLFIRI (day 1, irinotecan 180mg/m2, folinic acid 400 mg/m², and fluorouracil 400 mg/m² intravenous bolus, then continuous infusion for 46 hours of 2400 mg/m2).
Interventions
On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of cetuximab (initial dose 400 mg/m2 in week 1, and 250 mg/m2 weekly during 1 hour thereafter) followed after 1 hour by chemotherapy of FOLFOX or FOLFIRI until progressive disease or unacceptable toxicity.
FOLFOX-4 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV200mg/m2ondays 1and 2 infused during 2 hours, together with or following oxaliplatin; followed by FU 400 mg/m2 intravenous bolus then 600 mg/m2 intravenous infusion over 22 hours on days 1 and 2) FOLFIRI(irinotecan 180mg/m2 on day 1 infused during 2 hours; fluorouracil in a bolus of 400 mg/m2 and then continuous infusion for 46 hours of 2400 mg/m2)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤ 75 years;
- Primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;
- Together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases
- With evidence of tumor EGFR expression and KRAS gene wild-type status;
- With one measurable tumor.
- Performance status (ECOG) 0\~1
- A life expectancy of ≥ 3 months
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
- Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- Written informed consent for participation in the trial.
You may not qualify if:
- Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
- Known or suspected extrahepatic metastases.
- Patients with known hypersensitivity reactions to any of the components of the study treatments.
- Having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab)
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
- Acute or sub-acute intestinal occlusion
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Pre-existing peripheral neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xu jianminlead
Study Sites (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
Related Publications (1)
Ye LC, Liu TS, Ren L, Wei Y, Zhu DX, Zai SY, Ye QH, Yu Y, Xu B, Qin XY, Xu J. Randomized controlled trial of cetuximab plus chemotherapy for patients with KRAS wild-type unresectable colorectal liver-limited metastases. J Clin Oncol. 2013 Jun 1;31(16):1931-8. doi: 10.1200/JCO.2012.44.8308. Epub 2013 Apr 8.
PMID: 23569301DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Jianmin Xu, PhD Fudan University
Study Record Dates
First Submitted
March 26, 2012
First Posted
March 28, 2012
Study Start
September 1, 2006
Primary Completion
June 1, 2012
Study Completion
September 1, 2015
Last Updated
October 24, 2012
Record last verified: 2012-10