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

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Everolimus

Tubulin Modulators

Antimitotic Agents

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle

Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle

Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle

Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle

John D. Hainsworth, M.D.

Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.

Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

A Phase II Study of Everolimus in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Overall survival (OS) is defined as the time from randomization until death from any cause.

Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Novartis

SCRI Development Innovations, LLC

Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle

Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle

Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle

Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle

Spots Global Cancer Trial Database for Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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