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Sorafenib and FOLFIRI Regimen in 2nd Colorectal Cancer (CRC) After Failure of Oxaliplatin Treatment
This study is currently recruiting participants.
Verified by Fudan University, February 2009
First Received: February 6, 2009   Last Updated: February 9, 2009   History of Changes
Sponsored by: Fudan University
Information provided by: Fudan University
ClinicalTrials.gov Identifier: NCT00839111
  Purpose

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 Intervention Phase
Colorectal Neoplasms
Drug: sorafenib
Drug: FOLFIRI
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Oxaliplatin Irinotecan U 101440E Irinotecan hydrochloride Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) ,defined as the time from treatment to disease progression or death due to any cause [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: November 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Sorafenib plus FOLFIRI regimen
Drug: sorafenib
Sorafenib 400mg twice daily from d3 to d14,d17-28
Drug: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839111

Contacts
Contact: Zhiyu Chen, MD +862164175590 ext 1107 chanhj75@yahoo.com.cn

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

No publications provided

Responsible Party: Department of Medical Oncology, Cancer Hospital, Fuandan University. ( Base for drug clinical trials, Fudan University,cancer hospital. )
Study ID Numbers: Bay43-9006-2008005
Study First Received: February 6, 2009
Last Updated: February 9, 2009
ClinicalTrials.gov Identifier: NCT00839111     History of Changes
Health Authority: China: State Food and Drug Administration

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

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Disease Progression
Leucovorin
Intestinal Diseases
Protein Kinase Inhibitors
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Sorafenib
Colorectal Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Enzyme Inhibitors
Intestinal Diseases
Protein Kinase Inhibitors
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Sorafenib
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009