A controlled randomized double-blind multi-center phase II study of FOLFOX6 or FOLFIRI combined with sorafenib versus placebo in second-line metastatic colorectal carcinoma - FOLFOX6/FOLFIRI plus Sorafenib in second-line Colorectal cancer (FOSCO)

• Conditions: Patients with metastatic CRC who received a first-line therapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently, are eligible for this study.; MedDRA version: 14.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-000803-26-DE
• Lead Sponsor: AIO Studien gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-29
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age > 18 years
2. ECOG Performance Status of 0 to 2
3. Life expectancy of at least 12 weeks
4. Subjects with at least one uni-dimensional (RECIST) measurable lesion of
metastatic colorectal carcinoma after first-line chemotherapy with an
Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ±
bevacizumab and had a progression subsequently. Lesions must be
measured by CT-scan or MRI.
5. 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 ³ 100,000/µl
· Total bilirubin < 1.5 times the upper limit of normal
· ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for
patients with liver involvement of their cancer)
· Alkaline phosphatase < 4 x upper limit of normal
· PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being
therapeutically anticoagulated with an agent such as coumadin or heparin
will be allowed to participate provided that no prior evidence of underlying
abnormality in these parameters exists.]
· Serum creatinine < 1.5 x upper limit of normal
6. Signed and dated informed consent before the start of specific protocol
procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
2. History of HIV infection or chronic hepatitis B or C
3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
4. 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)
5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
6. History of organ allograft
7. Patients with evidence or history of bleeding diathesis
8. Patients undergoing renal dialysis
9. Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
10. Contraindications for the use of atropine in patients receiving FOLFIRI
11. 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, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
12. Peripheral sensory neuropathy > CTC grade 2
13. Chronic inflammatory bowel disease; ileus; genetic fructose intolerance
14. Pregnant or breast-feeding patients.
15. Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
16. Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results
17. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
18. Patients unable to swallow oral medications.

Excluded therapies and medications, previous and concomitant:
1. 1.Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
2. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
3. Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
4. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
5. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
6. Prior exposure to the study drug.
7. Any St. John´s wort containing remedy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified