EUCTR2007-001918-16-DEActive, not recruitingNot Applicable
Combined Treatment of Sorafenib and pegylated interferon a2b in stage IV metastatic melanoma: a prospective non-randomized, multicenter Phase II StudySoraPeg Trial - SoraPeg Trial
niversitätsklinikum Schleswig-Holstein, Campus Kiel0 sitesStarted: April 14, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Histologically documented metastatic melanoma classified as stage IV (AJCC 2002) of cutaneous origin.
- •2. = 18 years of age
- •3. ECOG performance status of 0 or 1
- •4. Patients should not have received any systemic treatment for stage IV disease (study = first-line” treatment).
- •Patients with progressive disease (PD) to stage IV under prior treatment with interferons as well as all patients who have already been treated with Sorafenib should not be included.
- •The following are allowed:
- •- adjuvant interferon treatment (without progressive disease during treatment!) or vaccine therapy for resected stage I-III disease
- •- palliative surgery or radiotherapy for stage IV disease
- •- prior cytokine or chemotherapy treatment for local-regional disease by isolated limb perfusion or intralesional therapy
- •5. Life expectancy >6 months.
- •6. Patients must have measurable disease defined as = 1 unidimensional measurable lesion = 20 mm (conventional techniques) or = 10 mm by spiral CT/MRI.
- •7. Patients must have adequate hematological, renal and liver functions as defined by laboratory values below performed within 14 days prior to study inclusion:
- •- absolute neutrophil count (ANC) > 1.5 x 109/l
- •- platelet count > 100 x 109/l
- •- hemoglobin > 10 g/dl (> 6.2 mmol/l)
- •- serum creatinine = 1.5 x upper limit of institutional values
- •- total serum bilirubin = 1.5x upper limit of institutional values
- •- ALAT or ASAT = 2.5x upper limit of institutional values (exception: liver metastases)
- •8. Patients should not suffer from frequent vomiting or medical conditions which could interfere with oral medication intake.
- •9. Negative pregnancy test performed within 7 days prior to the start of treatment.
- •10. Women of childbearing potential must agree to use an effective method of contraception.
- •11. Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.
- •12. Patients should understand the informed consent and will need to sign the consent.
- •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. Ocular or mucosal melanoma.
- •2. History or evidence of brain metastasis.
- •3. Patients with LDH values higher than 2x upper limit of institutional values.
- •4. Patients with thyroid dysfunctions not responsive to therapy.
- •5. Patients with uncontrolled diabetes mellitus.
- •6. Patients with active autoimmune disease.
- •7. Cardiac disease: congestive heart failure > class II NYHA, patients must not have unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy.
- •8. Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal management.
- •9. Active clinically serious infections > CTCAE Grade 2.
- •10. Patients who are HIV positive or have AIDS.
- •11. Thrombotic or embolic events including transient ischemic attacks within the past 6 months.
- •12. Evidence or history of bleeding diathesis or coagulopathy.
- •13. Therapeutic anticoagulation with Vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is < 1.5. Low dose aspirin is permitted.
- •14. Known or suspected allergy to Sorafenib, PEG-IFN-a-2b or any agent given in the course of this trial.
- •15. Previous cancer that is distinct in primary site or histology from melanoma except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry.
- •16. Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study.
- •17. Patients with medication requiring chronic systemic corticosteroids.
- •18. Patients with prior systemic anticancer treatment in the last 2 weeks.
- •19. Patients with severe liver disease or severe renal disease.
- •20. Patients with seizure disorders requiring anticonvulsant therapy.
Investigators
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