Sorafenib and FOLFIRI Regimen in 2nd Colorectal Cancer (CRC) After Failure of Oxaliplatin Treatment

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: NCT00839111
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : February 9, 2009
Last Update Posted : September 15, 2010
Information provided by:
Fudan University

Brief Summary:
The purpose of this study is to evaluate the Progression-Free Survival (PFS) time of Sorafenib in combination with FOLFIRI regimen used as in the second front treatment in patients with advanced CRC after failure of oxaliplatin treatment.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: sorafenib Drug: FOLFIRI Phase 2

Detailed Description:
This is a phase Ⅱ open label, non randomized study, in which sorafenib is used in combination with irinotecan, leucovorin and fluorouracil in patients with advanced colorectal cancer after failure of oxaliplatin treatment.The aim of this study is to determine the Progression-Free Survival (PFS) of Sorafenib used in combination with FOLFIRI regimen as a second front treatment in patients with advanced CRC after failure of oxaliplatin treatment, defined as the time from treatment to disease progression or death due to any cause. The other secondary endpoints are disease control rate, defined as complete response, partial response, and stable disease.Response rate,overall survival, and safety are also evaluated.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅱ Open Label, Non Randomized Study, in Which Sorafenib is Used in Combination With Irinotecan, Leucovorin and Fluorouracil in Patients With Advanced Colorectal Cancer After Failure of Oxaliplatin Treatment
Study Start Date : November 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Sorafenib plus FOLFIRI regimen
Drug: sorafenib
Sorafenib 400mg twice daily from d3 to d14,d17-28
Other Name: Nexavar

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 Name: Irinotecan:Campto

Primary Outcome Measures :
  1. Progression-Free Survival (PFS) ,defined as the time from treatment to disease progression or death due to any cause [ Time Frame: every 8 weeks ]

Secondary Outcome Measures :
  1. Secondary endpoints are disease control rate, defined as a complete response, partial response, and stable disease; Response rate and overall survival; and safety are also evaluated. [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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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:

  1. Provision of written informed consent
  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:

  1. Patients unable to swallow oral medications
  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.

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): NCT00839111

Contact: Zhiyu Chen, MD +862164175590 ext 1107

China, Shanghai
Cancer Hospital,Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yanfei Liu, Master    +862164175590 ext 1107      
Sponsors and Collaborators
Fudan University
Principal Investigator: Jin Li, MD Cancer Hospital,Fudan University

Responsible Party: Base for drug clinical trials, Fudan University,cancer hospital., Department of Medical Oncology, Cancer Hospital, Fuandan University. Identifier: NCT00839111     History of Changes
Other Study ID Numbers: Bay43-9006-2008005
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Keywords provided by Fudan University:
Progression free survival
Response rate
overall survival

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs