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Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye
This study is ongoing, but not recruiting participants.
First Received: May 23, 2006   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00329641
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well sorafenib works when given together with carboplatin and paclitaxel in treating patients with stage IV melanoma of the eye.


Condition Intervention Phase
Intraocular Melanoma
Drug: carboplatin
Drug: paclitaxel
Drug: sorafenib tosylate
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: Phase II Trial of BAY 43-9006 (SORAFENIB; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (confirmed and unconfirmed, complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxic effects [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate (confirmed and unconfirmed, complete and partial response) of patients with stage IV uveal melanoma treated with sorafenib, carboplatin, and paclitaxel.

Secondary

  • Determine the overall and progression-free survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine, preliminarily, the relationship between clinical outcomes and baseline microvessel density (MVD) in tumor specimens, changes in vascular endothelial growth factor (VEGF) levels in plasma and urine, changes in MVD, changes in VEGF receptor-2 phosphorylation in tumor, and/or changes in ERK 1/2 phosphorylation in stimulated lymphocytes and tumor.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive carboplatin IV and paclitaxel IV once on day 1 and oral sorafenib twice daily on days 2-19.

Treatment repeats every 21 days for up to 6 courses.* After 6 courses, patients continue to receive oral sorafenib alone twice daily in the absence of disease progression or unacceptable toxicity.

NOTE: *If sorafenib is discontinued prior to course 6, patients may continue to receive carboplatin and paclitaxel for up to 6 courses; if carboplatin and paclitaxel are discontinued prior to course 6, patients may continue to receive sorafenib alone twice daily on days 1-21 of each course in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven uveal melanoma

    • Stage IV disease
  • Must have documented disease progression during or after ≤ 1 prior systemic treatment
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or

    • 10 mm by spiral CT scan
  • No tumor involving major vessels

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Creatinine ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • SGOT or SGPT ≤ 2 times ULN (5 times ULN if hepatic metastasis present)
  • INR in range (usually between 2 and 3)
  • No active bleeding
  • No bleeding diathesis, active coagulopathy, or pathological condition that carries a high risk of bleeding
  • No known varices
  • No uncontrolled hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
  • No significant traumatic injury within the past 21 days
  • No condition (e.g., gastrointestinal tract disease) affecting ability to take oral medication or requiring IV alimentation
  • No active, uncontrolled peptic ulcer disease
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 28 days since prior systemic treatment for this disease comprising 1 of the following:

    • Single chemotherapy agent/regimen
    • Single immunotherapy agent/regimen
    • Single investigational treatment agent/regimen
  • At least 21 days since prior major surgery
  • No prior sorafenib or any other agents targeting raf kinase or vascular endothelial growth factor (VEGF) or VEGF receptor
  • No prior surgical procedures affecting absorption
  • No concurrent systemic corticosteroid therapy

    • Topical and/or inhaled steroids are allowed
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, and phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
  • No prophylactic granulocyte/platelet colony-stimulating factors during the first course of treatment
  • Concurrent full-dose oral anticoagulants (e.g., warfarin) are allowed provided all of the following criteria are met:

    • In-range INR
    • Stable dose of oral anticoagulant
    • No active bleeding or high risk of bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329641

  Show 48 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Ana Aparicio, MD M.D. Anderson Cancer Center
Investigator: Jeffrey S. Weber, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers: CDR0000467188, SWOG-S0512
Study First Received: May 23, 2006
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00329641     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
ciliary body and choroid melanoma, medium/large size
iris melanoma
recurrent intraocular melanoma
extraocular extension melanoma
metastatic intraocular melanoma

Study placed in the following topic categories:
Eye Neoplasms
Uveal Melanoma
Eye Diseases
Melanoma of the Choroid
Antimitotic Agents
Carboplatin
Protein Kinase Inhibitors
Recurrence
Melanoma
Neuroendocrine Tumors
Ocular Melanoma
Neuroectodermal Tumors
Paclitaxel
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Tubulin Modulators
Intraocular Melanoma
Neuroepithelioma
Nevus
Antineoplastic Agents, Phytogenic
Sorafenib

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Eye Neoplasms
Antineoplastic Agents
Eye Diseases
Mitosis Modulators
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Protein Kinase Inhibitors
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Phytogenic
Sorafenib

ClinicalTrials.gov processed this record on September 11, 2009