|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 October 2012 |
|
Main ID: |
NCT00433927 |
|
Date of registration:
|
09/02/2007 |
|
Primary sponsor: |
|
|
Public title:
|
5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC)
|
|
Scientific title:
|
Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer. |
|
Date of first enrolment:
|
January 2007 |
|
Target sample size:
|
568 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00433927 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Volker Heinemann, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Munich - Klinikum Grosshadern |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- KRAS-Wildtype status
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Stage IV disease.
- ECOG 0-2.
- Patients considered suitable for application of chemotherapy.
- Age 18 - 75 years.
- In- or outpatient treatment.
- Estimated life expectancy > 3 months.
- Measurable index lesion according to RECIST criteria. Evaluation of tumor
manifestations = 2 weeks prior to treatment start.
- Effective contraception.
- Adequate hematologic function: leukocytes >= 3000/µl, neutrophils >= 1500/µl,
platelets >= 100.000/µ, and hemoglobin >= 9g/dl.
- Bilirubin <= 1,5x upper limit of normal (ULN).
- ALAT and ASAT <= 2,5x ULN, in case of liver metastases <= 5x ULN.
- Serum creatinine <= 1,5x ULN.
- No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1
week prior to treatment start. Operation sequels need to be completely healed. Major
operations must not be expected at time of study begin, except for potential
secondary resection of liver metastases. In case of secondary resection of liver
metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.
- No relevant toxicities due to prior medical treatment at time of study entry.
Exclusion Criteria:
- KRAS-Mutation of the tumor
- Prior treatment directed against the epidermal growth factor receptor (EGFR).
- Prior treatment with bevacizumab.
- Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating
back > 6 months prior to study entry.
- Experimental medical treatment within 30 days prior to study entry.
- Known hypersensitivity reaction to any study medication.
- Pregnant or breast feeding women (pregnancy needs to be excluded by testing of
beta-HCG).
- Known or suspected cerebral metastases.
- Clinically significant coronary heart disease, myocardial infarction within the last
12 months or high risk of uncontrolled arrhythmia.
- Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.
- Symptomatic peritoneal carcinosis.
- Severe chronic wounds, ulcera or bone fracture.
- Uncontrolled hypertension.
- Severe proteinuria (nephrotic syndrome).
- Arterial thromboembolic events or hemorrhage within 6 months prior to study entry
(except tumor bleeding surgically treated by tumor resection).
- Bleeding diatheses or coagulopathy.
- Full dose anticoagulation.
- Known DPD-deficiency (special screening not required).
- Known glucuronidation-deficiency (special screening not required).
- Medical history of other malignant disease within 5 years prior to study entry,
except for basalioma, and in-situ cervical carcinoma if treated with curative intent.
- Known alcohol or drug abuse.
- Medical or psychiatric condition which contradicts participation of study.
- Limited legal capacity.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Colorectal Cancer
|
|
Neoplasm Metastasis
|
|
Intervention(s)
|
|
Drug: 5-FU
|
|
Drug: bevacizumab
|
|
Drug: cetuximab
|
|
Drug: folinic acid
|
|
Drug: irinotecan
|
|
Primary Outcome(s)
|
|
Objective response rate
[Time Frame: approximate 6 months after randomisation]
|
|
Secondary Outcome(s)
|
|
Median overall survival
[Time Frame: approximate 3 years after randomisation]
|
|
Median progression free survival
[Time Frame: approximate 6 months after randomisation]
|
|
Safety and toxicity (according to NCI-CTCAE)
[Time Frame: approximate 6 months after randomisation]
|
|
Secondary resection rate with curative intent
[Time Frame: up to 3 months after end of treatment]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|