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

NCT00839111 | Unknown Phase 2

• 1 other identifier: Bay43-9006-2008005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Progression free survival; Toxicity; Response rate; overall survival

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) ,defined as the time from treatment to disease progression or death due to any cause

  every 8 weeks

Secondary Outcomes (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.

  every 8 weeks

Study Arms (1)

A

EXPERIMENTAL

Sorafenib plus FOLFIRI regimen

Drug: sorafenib; Drug: FOLFIRI

Interventions

sorafenib DRUG

Sorafenib 400mg twice daily from d3 to d14,d17-28

Also known as: Nexavar

A

FOLFIRI DRUG

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

Also known as: Irinotecan:Campto

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Histological or cytological confirmed adenocarcinoma of the colon or rectum
• Age between 18 and 75 years.
• 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.
• ECOG Performance Status of 0 or1
• Life expectancy of at least 12 weeks
• 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)
• 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

You may not qualify if:

• Patients unable to swallow oral medications
• 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
• History of HIV infection or chronic hepatitis B or C (high copy number of HBV).
• Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
• 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)
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
• History of organ allograft ,The organ allograft may be allowed as protocol specific.
• Patients undergoing renal dialysis
• 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.
• 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.
• chronic inflammatory bowel disease; ileus; genetic fructose intolerance
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital,Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Sorafenib; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jin Li, MD

  Cancer Hospital,Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyu Chen, MD

CONTACT

+862164175590; chanhj75@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 15, 2010

Record last verified: 2010-09

Locations

CN (1)