Biweekly Bevacizumab and weekly Carboplatin and Paclitaxel as II line therapy in advanced Malignant Melanoma patients: a phase II study - Bevacizumab in advanced melanoma

• Conditions: patients with histologically confirmed progressive metastastic melanoma progressed after first line chemotherapy.; MedDRA version: 9.1Level: SOCClassification code 10040785; MedDRA version: 9.1Level: LLTClassification code 10027480

• Registration Number: EUCTR2008-006191-30-IT
• Lead Sponsor: ISTITUTO DERMOPATICO IMMACOLATA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients over 18 and less than 75 years of age. Histologically confirmed progressive metastastic or locally advanced melanoma, not amenable to surgery. No more than 1 prior systemic chemotherapy regimen No prior carboplatin or paclitaxel No other concurrent chemotherapy At least one bidimensionally measurable tumor lesions according to the Response Evaluation Criteria in Solid Tumors RECIST criteria, with documented progression within 2 weeks prior to entry is required (lesions in previously irradiated fields are not considered measurable). Patients must have an ECOG performance status of 2 or better. Patients must have a life expectancy of at least 3 months. No standard treatment indicated. WBC more than 4,000/cumm (polyneutrophils more than 2,000/cumm), platelets more than 100,000/cumm, hemoglobin more than 10 g/dl, serum creatinine no more than 2.5 mg/dl, Total bilirubin > 1.5 times the upper limit of institutional normal values (ULN), GOT and GPT < 1.5 times the ULN (unless liver metastasis are present). Signed informed 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

Patients with metastatic disease in the central nervous system (CNS). Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin). Patients previously treated with chemotherapeutic regimen including carboplatin, paclitaxel and/or bevacizumab. Concomitant immunotherapy Radiotherapy (except to a nonhematopoietic site) within the previous 28 days. Patients with an history of acute heart infarction, congestive heart failure or any uncontrolled cardiac disease, active infection. Patients with acute or chronic infection including HIV, hepatitis and tuberculosis. Symptomatic: peripheral neuropathy, >2 grade by NCIC-CTG criteria Definite contra-indications for the use of corticosteroids: unstable diabetes mellitus, active peptic ulcer; Baseline serum LDH greater than 1.5 folds the upper limit of normal. Concurrent administration of: corticosteroids or equivalent except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment (initiated >6 months prior to study entry) at low doses (<20mg methylprednisolone or equivalent); any other experimental drug under investigation: concurrent treatment with any other anticancer therapy, growth factors with preventive intent; Patients who are pregnant or breast-feeding.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the percentage of partial and complete responses obtained with this drug assoctions in patients with advanced melanoma, in a Phase II trial. To determine the toxicity profile of this regimen in these patients.;Secondary Objective: To evaluate the overall survival rate of the association between biweekly Bevacizumab and weekly carboplatin and paclitaxel as IInd line therapy in malignant melanoma patients. To identify possible markers predictive of patient responsiveness or early indicators of clinical response, serum levels of VEGF, PlGF, sVEGFR-1,VCAM, E-Selectin and von Willebrand factor will be determined in patients before the first, second and third cycle of treatment.;Primary end point(s): To evaluate the percentage of partial and complete responses obtained with this drug assoctions in patients with advanced melanoma, in a Phase II trial.