Sorafenib and FOLFIRI Regimen in 2nd Colorectal Cancer (CRC) After Failure of Oxaliplatin Treatment
NCT ID: NCT00839111
Last Updated: 2010-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
43 participants
INTERVENTIONAL
2008-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Sorafenib plus FOLFIRI regimen
sorafenib
Sorafenib 400mg twice daily from d3 to d14,d17-28
FOLFIRI
Irinotecan 180 mg/m2,CF 400mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
Interventions
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sorafenib
Sorafenib 400mg twice daily from d3 to d14,d17-28
FOLFIRI
Irinotecan 180 mg/m2,CF 400mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological confirmed adenocarcinoma of the colon or rectum
3. Age between 18 and 75 years.
4. Patient with metastatic disease failed after at least 2 cycles of oxaliplatin-based systemic chemotherapy, excluding adjuvant chemotherapy. Disease progression should be proven by radiological evidence. A duration of 28 days after oxaliplatin therapy is also required.
5. ECOG Performance Status of 0 or1
6. Life expectancy of at least 12 weeks
7. The required evidence of measurable lesions should be at least 10 mm in the longest diameter by spiral computed tomography scan or 20 mm with conventional techniques (RECIST criteria)
8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
* Hemoglobin \> 9.0 g/dl
* Absolute neutrophil count (ANC) \>1,500/mm3
* Platelet count 100,000/μl
* Total bilirubin \< 1.5 times the upper limit of normal ALT and AST \< 2.5 x ULN(\< 5 x ULN for patients with liver involvement of their cancer)
* ALP\< 4 x ULN
* PT-INR/PTT \< 1.5 x upper limit of normal
* Serum creatinine \< 1.5 x ULN
Exclusion Criteria
2. History of cardiac disease:
* congestive heart failure \>NYHA class 2
* active CAD (MI more than 6 mo prior to study entry is allowed)
* cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
3. History of HIV infection or chronic hepatitis B or C (high copy number of HBV).
4. Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
5. Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
6. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
7. History of organ allograft ,The organ allograft may be allowed as protocol specific.
8. Patients undergoing renal dialysis
9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma within 5 years.
10. Patients with evidence or history of bleeding diathesis.Significant haemorrhage (\>30 ml/bleeding episode in previous 3 months),haemoptysis (\>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months.
11. chronic inflammatory bowel disease; ileus; genetic fructose intolerance
12. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
13. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
14. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
15. Prior exposure to the study drug.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Department of Medical Oncology, Cancer Hospital, Fuandan University.
Principal Investigators
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Jin Li, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital,Fudan University
Locations
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Cancer Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yanfei Liu, Master
Role: primary
Other Identifiers
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Bay43-9006-2008005
Identifier Type: -
Identifier Source: org_study_id