A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00111007

Purpose

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of sorafenib in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing dacarbazine (DTIC) or temozolomide (TMZ).

Condition	Intervention	Phase
Cancer Melanoma	Drug: Nexavar (Sorafenib, BAY43-9006) plus carboplatin/paclitaxel Drug: carboplatin/paclitaxel	Phase III

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Carboplatin Paclitaxel Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary objective is to evaluate progression free survival (PFS) between subjects treated with sorafenib versus placebo in combination with paclitaxel and carboplatin. [ Time Frame: 31. March 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event collection [ Time Frame: 31. March 2008 ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 31. March 2008 ] [ Designated as safety issue: No ]
Time to progression (TTP) [ Time Frame: 31. March 2008 ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 31. March 2008 ] [ Designated as safety issue: No ]
Change from baseline in performance status [ Time Frame: 31. March 2008 ] [ Designated as safety issue: No ]
Change from baseline in the EQ-5D scales [ Time Frame: 31. March 2008 ] [ Designated as safety issue: No ]

Enrollment:	270
Study Start Date:	May 2005
Estimated Study Completion Date:	February 2009
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY43-9006) plus carboplatin/paclitaxel multikinase inhibitor plus chemotherapy: Sorafenib, 400 mg po, 2 tablets (200 mg each) bid Study Days 2-19 + paclitaxel (225 mg/m2 iv) and carboplatin (AUC 6 iv) on Study Day 1
Arm 2: Active Comparator	Drug: carboplatin/paclitaxel Group B: Placebo, 2 tablets bid Study Days 2-19 + paclitaxel (225 mg/m2 iv) and carboplatin (AUC 6 iv) on Study Day 1

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have a life expectancy of at least 12 weeks
Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
Patients must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
Patients who have an ECOG PS of 0, or 1
Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria

Exclusion Criteria:

Primary ocular or mucosal melanoma
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 & Ti) or any cancer curatively treated < 3 years prior to study entry
History of cardiac disease
Known history of human immunodeficiency virus (HIV) infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111007

Show 60 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	11718, EudraCT 2005-000941-12
Study First Received:	May 16, 2005
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00111007
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors
Paclitaxel
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Carboplatin
Nevus
Sorafenib
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents

Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009