Status:
COMPLETED
Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Ciliary Body and Choroid Melanoma, Medium/Large Size
Extraocular Extension Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Drugs used in chemotherapy, such as...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate (confirmed and unconfirmed, complete and partial response) of patients with stage IV uveal melanoma treated with sorafenib, carboplatin, and paclita...
Eligibility Criteria
Inclusion
- Criteria:
- Histologically proven uveal melanoma
- 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
- 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 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
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00329641
Start Date
February 1 2011
End Date
November 1 2012
Last Update
July 31 2014
Active Locations (1)
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1
Southwest Oncology Group
San Antonio, Texas, United States, 78245