Monocentric, open label, uncontrolled phase I-II study to evaluate the safety and the maximum tolerated dose of sorafenib given daily in combination with temozolomide (extended schedule) in patients with metastatic melanoma - Soraf-Tem
- Conditions
- metastatic melanoma
- Registration Number
- EUCTR2007-000527-18-FR
- Lead Sponsor
- Institut Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1) Unresectable metastatic stage III or IV melanoma
2) Previously or non-previously treated for metastatic disease
3) Men and women =18 years, WHO performance status of 0 or 1 and life expectancy > 3 months
4) Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST), evaluated within 28 days prior to inclusion.
5) Adequate bone marrow function as assessed by the following laboratory requirements to be conducted within 7 days prior to inclusion: hemoglobin >9.0 g/dl, absolute neutrophil count (ANC)>1,500/mm3, platelets> or = 100,000/mm3.
6) Adequate liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to inclusion: ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer). Total bilirubin < 1.5 x the upper limit of normal. Amylase and lipase < 1.5 x the upper limit of normal.
7) Adequate renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to inclusion: Serum creatinine < 1.5 x the upper limit of normal.
8) Adequate coagulation function as assessed by the following laboratory requirements to be conducted within 7 days prior to inclusion: PT or INR and PTT < 1.5 x upper limit of normal (patients who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care).
9) Vital functions : respiratory, cardiac and neurologic in the normal ranges.
10) Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
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
1) Known evolutive CNS tumors including metastatic brain disease.
2) Known or suspected allergy to the investigational agent or dacarbazine or any agent to be administered in the trial.
3) Anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies), hormonal therapy, or investigational drug within 30 days prior to start of study drug. 4) Prior use of temozolomide or sorafenib.
5) Radiotherapy within 3 weeks of start of study drug.
6) Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry.
7) History of cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); active coronary artery disease (CAD), history of myocardial infarction less than 6 months prior to study entry; cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, uncontrolled hypertension.
8) Active clinically serious infection (> grade 2 NCI-CTCAE version 3.0).
9) Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
10) Patients with seizure disorder requiring medication (such as anti-epileptics).
11) History of organ allograft.
12) History of lactase deficiency, galactokinase-deficiency galactosemia, glucose or galactose malabsorption syndrome.
13) 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) and any cancer curatively treated > 3 years prior to study entry.
14) Participation in another clinical trial and administration of any investigational drug within 30 days prior to study screening.
15) Pregnant women or breast feeding, women of child-bearing potential.
16) People deprived of freedom or under supervision (including trusteeship).
17) Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study; substance abuse, medical, psychological, social or geographic conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
18) Patients unable to swallow oral medications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method