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Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma

Phase 2
18 Years
Open (Enrolling)
Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Metastatic Intraocular Melanoma, Recurrent Intraocular Melanoma

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Trial Information

Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma


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


I. Determine the overall and progression-free survival of patients treated with this

II. Determine the toxic effects of this regimen in these patients. III. 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 non-randomized, 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.

Inclusion Criteria


- Histologically proven uveal melanoma

- Must have documented disease progression during or after =< 1 prior systemic

- 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

- 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 condition (e.g., gastrointestinal tract disease) affecting ability to take oral
medication or requiring IV alimentation

- 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

- 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

- 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

- Stage IV disease

- 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 active, uncontrolled peptic ulcer disease

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Complete and Partial Response)

Outcome Description:

Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.

Outcome Time Frame:

Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression

Safety Issue:


Principal Investigator

Ana Aparicio

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Metastatic Intraocular Melanoma
  • Recurrent Intraocular Melanoma
  • Melanoma
  • Uveal Neoplasms



Southwest Oncology Group San Antonio, Texas  78245