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

NCT00111007 | Completed Phase 3 Results DMC

• 2 other identifiers: 117182005-000941-12
• Study Type: interventional
• Target: 270
• Locations: 7 countries
• Sites: 66

Brief Summary

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).

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors \[RECIST\] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.

  Time from randomization to documented tumor progression or death (median time of 124 days)

Secondary Outcomes (4)

• Overall Survival (OS)

  Time from randomization to death (median time of 294 days)

• Time to Progression (TTP)

  Time from randomization to documented tumor progression (median time of 126 days)

• Duration of Response (DOR)

  Time from initial response to documented tumor progression or death (median time of 197 days)

• Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted

  baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)

Study Arms (2)

Sorafenib (Nexavar, BAY43-9006)

EXPERIMENTAL

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.

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

Carboplatin/Paclitaxel (C/P)

ACTIVE COMPARATOR

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.

Drug: Carboplatin/Paclitaxel; Drug: Placebo

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19

Sorafenib (Nexavar, BAY43-9006)

Carboplatin/Paclitaxel DRUG

Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1

Carboplatin/Paclitaxel (C/P); Sorafenib (Nexavar, BAY43-9006)

Placebo DRUG

Placebo, 2 tablets bid Study Days 2-19

Carboplatin/Paclitaxel (C/P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Amgen: collaborator

Study Sites (66)

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Birmingham, Alabama, 35243, United States

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Tucson, Arizona, 85724, United States

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Los Angeles, California, 90025, United States

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Aurora, Colorado, 80045, United States

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Tampa, Florida, 33612, United States

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Chicago, Illinois, 60612, United States

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Park Ridge, Illinois, 60068, United States

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Louisville, Kentucky, 40202, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68114, United States

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Montclair, New Jersey, 07042, United States

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Buffalo, New York, 14263, United States

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New York, New York, 10065, United States

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Columbus, Ohio, 43221, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Nashville, Tennessee, 37232-6307, United States

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Houston, Texas, 77030, United States

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Charlottesville, Virginia, 22908, United States

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Seattle, Washington, 98109-1023, United States

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Camperdown, New South Wales, 2050, Australia

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Warartah, New South Wales, 2300, Australia

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Westmead, New South Wales, 2145, Australia

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Brisbane, Queensland, 4101, Australia

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East Melbourne, Victoria, 3002, Australia

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Heidelberg, Victoria, 3084, Australia

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Malvern, Victoria, 3144, Australia

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Melbourne, Victoria, 3004, Australia

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Nedlands, Western Australia, 6009, Australia

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Calgary, Alberta, T2N 4N2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Bordeaux, 33000, France

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Boulogne-Billancourt, 92104, France

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Brest, 29285, France

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Lyon, 39373, France

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Montpellier, 34298, France

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Paris, 75010, France

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Paris, 75634, France

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Villejuif, 94805, France

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Heidelberg, Baden-Wurttemberg, 69112, Germany

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Mannheim, Baden-Wurttemberg, 68135, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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München, Bavaria, 81675, Germany

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Frankfurt am Main, Hesse, 60488, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Trier, Rhineland-Palatinate, 54290, Germany

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Homburg, Saarland, 66421, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Berlin, State of Berlin, 12200, Germany

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Amsterdam, 1066 CX, Netherlands

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Rotterdam, 3075 EA, Netherlands

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Utrecht, 3584 CX, Netherlands

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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London, London, SE1 9RT, United Kingdom

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London, London, SW3 6JJ, United Kingdom

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Manchester, Manchester, M20 4BX, United Kingdom

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Bebington, Merseyside, CH63 4JY, United Kingdom

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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Related Publications (1)

• Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. doi: 10.1200/JCO.2007.15.7636. Epub 2009 Apr 6.

  PMID: 19349552 RESULT

Related Links

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MeSH Terms

Conditions

Melanoma

Interventions

Sorafenib; CP protocol

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Metastatic melanoma is notorious for its resistance to chemotherapy. Thus, it is unlikely that inhibition of a single factor or pathway would produce a sustained clinical effect in patients with previously treated, highly refractory disease.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2005
• First Posted: May 17, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: January 1, 2009
• Last Updated: October 31, 2014
• Results First Posted: February 23, 2011

Record last verified: 2014-10

Locations

NL (3); AU (9); FR (8); GB (10); CA (6); US (19); DE (11)