Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study)

bevacizumab

Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles

carboplatin

175 mg/m\^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change)

paclitaxel

Administered by IV infusion on the first day of each 3-week cycle

placebo

Richard Schwartz, M.D.

This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.

A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan-Meier method.

Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan-Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.

Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.

Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.

The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution.

Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.

Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan-Meier method.

As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.

The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day.

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade \>= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade \>= 3), neutropenia (Grade \>= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade \>= 3).

\*All serious adverse events are listed in the Adverse Event Reporting section.

Genentech, Inc.

Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment

Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.

Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.

Carboplatin+Paclitaxel+Placebo

Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.

Carboplatin+Paclitaxel+Bevacizumab

Total

Age, Continuous

<= 65 years

> 65 years

Age, Customized

Sex: Female, Male

Medical Communications

Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.

Progression-free Survival

Overall Survival (OS)

Number of Participants With Objective Response

Randomized Patients with Measurable Disease at Baseline

Percentage of Participants With an Objective Response

Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response

Duration of Objective Response

Six-month Landmark Survival Rate

Twenty-Four Week Landmark Stable Disease

Arterial thromboembolic events (any grade)

Bleeding other than pulmonary or CNS (Grade >=3)

CNS bleeding (any grade)

Febrile neutropenia (any grade)

Hypertension (Grade >= 3)

Neutropenia (Grade >= 3)

Pulmonary bleeding (any grade)

Wound dehiscence (Grade >= 3)

The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.

Spots Global Cancer Trial Database for A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial