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MelanomaPhase 3NCT00111007

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

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) and Carboplatin/Paclitaxel in people with Melanoma, run by Bayer at 66 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Sorafenib (Nexavar, BAY43-9006) and Carboplatin/Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
66 sitesin 7 countries
Study dates
May 2005to Jan 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

66 sites in 7 countries.

66 sites in 7 countries

United States19 sites

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Birmingham, Alabama, 35243

  • Study site

    Buffalo, New York, 14263

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Columbus, Ohio, 43221

  • Study site

    Houston, Texas, 77030

  • Study site

    Los Angeles, California, 90025

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Montclair, New Jersey, 07042

  • Study site

    Nashville, Tennessee, 37232-6307

  • Study site

    New York, New York, 10065

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Park Ridge, Illinois, 60068

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Seattle, Washington, 98109-1023

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tucson, Arizona, 85724

Other trials in United States

Germany11 sites

  • Study site

    Berlin, State of Berlin, 12200

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Frankfurt am Main, Hesse, 60488

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Heidelberg, Baden-Wurttemberg, 69112

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Kiel, Schleswig-Holstein, 24105

  • Study site

    Mannheim, Baden-Wurttemberg, 68135

  • Study site

    München, Bavaria, 81675

  • Study site

    Trier, Rhineland-Palatinate, 54290

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

United Kingdom10 sites

  • Study site

    Bebington, Merseyside, CH63 4JY

  • Study site

    Leeds, West Yorkshire, LS9 7TF

  • Study site

    Leicester, Leicestershire, LE1 5WW

  • Study site

    London, London, SE1 9RT

  • Study site

    London, London, SW3 6JJ

  • Study site

    Manchester, Manchester, M20 4BX

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB

  • Study site

    Southampton, Hampshire, SO16 6YD

  • Study site

    Sutton, Surrey, SM2 5PT

  • Study site

    Swansea, SA2 8QA

Other trials in United Kingdom

Australia9 sites

  • Study site

    Brisbane, Queensland, 4101

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    East Melbourne, Victoria, 3002

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Malvern, Victoria, 3144

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Warartah, New South Wales, 2300

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

France8 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Boulogne-Billancourt, 92104

  • Study site

    Brest, 29285

  • Study site

    Lyon, 39373

  • Study site

    Montpellier, 34298

  • Study site

    Paris, 75010

  • Study site

    Paris, 75634

  • Study site

    Villejuif, 94805

Other trials in France

Canada6 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands3 sites

  • Study site

    Amsterdam, 1066 CX

  • Study site

    Rotterdam, 3075 EA

  • Study site

    Utrecht, 3584 CX

Other trials in Netherlands

About this 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.

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
Being tested
Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel, Placebo
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006)Drug

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

  • Carboplatin/PaclitaxelDrug

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

  • PlaceboDrug

    Placebo, 2 tablets bid Study Days 2-19

Study groups in NCT00111007
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalSorafenib, 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.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel (C/P)Active comparatorPlacebo, 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.
Receives: Drug: Carboplatin/Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Overall Survival (OS)

    Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.

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

  2. Time to Progression (TTP)

    TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.

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

  3. Duration of Response (DOR)

    Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.

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

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

    Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionSep 2006
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111007
Sponsor's protocol ID
11718
Other IDs
2005-000941-12, 2005
Status last verified
Oct 2014
First submitted
16 May 2005
Last updated
31 Oct 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19349552

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) and Carboplatin/Paclitaxel in people with Melanoma, run by Bayer at 66 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Germany, United Kingdom, Australia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Time from randomization to documented tumor progression or death (median time of 124 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.

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