Patients with clinical evidence of metastatic melanoma and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease. MedDRA version: 14.1 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Current Sponsor code: RO 4876646-000
Concentration unit: mg milligram(s)
Concent
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed cutaneous malignant melanoma 2. Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease 3. Age = 18 4. ECOG Performance Status 0-1 5. Life expectancy of at least 12 weeks 6. Measurable and/or evaluable lesions according to RECIST criteria 7. Laboratory requirements: - Neutrophils =1.5 x 109/L and Platelets =100 x 109/L - Total bilirubin =1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) =2.5 x UNL, or =5 x UNL in case of liver metastases, alkaline phosphatase =2.5 x UNL, = 5 x UNL in case of liver metastases, =10 x UNL in case of bone metastases. - Creatinine clearance >50 mL/min or serum creatinine =1.5 x UNL) - Urine dipstick of proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. At least 4 weeks since prior adjuvant therapy with interferon alfa 2. Prior interferon alfa and/or cytokine therapy (e.g., high dose interleukin-2) for metastatic disease 3. Prior investigational antiangiogenic agents 4. Prior chemotherapy regimen for metastatic disease 5. Radiotherapy to any site within 4 weeks before the study. 6. Symptomatic and/or unstable pre-existing brain metastases (CT or MRI of the head is required within 4 weeks prior to treatment start). 7. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 8. Serious non-healing wound or ulcer. 9. Evidence of bleeding diathesis or coagulopathy. 10. Uncontrolled hypertension. 11. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (=6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. 12. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. 13. Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration. 14. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications 15. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 17. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the preliminary antitumor activity in terms of overall response rate (complete and partial responses) of bevacizumab in combination with dacarbazine.;Secondary Objective: - To evaluate toxicity and the safety profile of the combination. - To evaluate duration of response (DR), time to progression (TTP), time to treatment failure (TTF) and overall survival.;Primary end point(s): Best tumor response at any time during therapy.;Timepoint(s) of evaluation of this end point: nd | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): .;Timepoint(s) of evaluation of this end point: nd | — |
Countries
Italy
Contacts
Public ContactMedical Affairs&Clinical Operations
Roche S.p.A.
Outcome results
None listed