A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

Bayer

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Drug: Carboplatin/Paclitaxel; Drug: Placebo; Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111007

11718

2005-000941-12 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have a life expectancy of at least 12 weeks
• Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
• Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
• Subjects 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 [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 5 years prior to study entry
• History of cardiac disease
• Known history of human immunodeficiency virus (HIV) infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 2 patient groups

Sorafenib (Nexavar, BAY43-9006)

Experimental group

Description:

Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die \[twice daily\]) on Study Days 2 to 19 + Paclitaxel (225 mg/m\^2 iv \[Intravenous\]) and Carboplatin (AUC \[area under the curve\] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.

Treatment:

Drug: Carboplatin/Paclitaxel

Drug: Sorafenib (Nexavar, BAY43-9006)

Carboplatin/Paclitaxel (C/P)

Active Comparator group

Description:

Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.

Treatment:

Drug: Carboplatin/Paclitaxel

Drug: Placebo