Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye

NCT00329641 | Completed Phase 2 Results

• 4 other identifiers: NCI-2009-00777CDR0000467188S0512U10CA032102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response Rate (Complete and Partial Response)

  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.

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

Secondary Outcomes (3)

• One-year Overall Survival

  Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death

• 6-month Progression-free Survival

  Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death

• Toxicity

  Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)

Study Arms (1)

Treatment (carboplatin, paclitaxel, sorafenib)

EXPERIMENTAL

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

Drug: carboplatin; Drug: paclitaxel; Drug: sorafenib tosylate

Interventions

carboplatin DRUG

Given IV

Treatment (carboplatin, paclitaxel, sorafenib)

paclitaxel DRUG

Given IV

Treatment (carboplatin, paclitaxel, sorafenib)

sorafenib tosylate DRUG

Given orally

Treatment (carboplatin, paclitaxel, sorafenib)

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

Related Publications (1)

• Bhatia S, Moon J, Margolin KA, Weber JS, Lao CD, Othus M, Aparicio AM, Ribas A, Sondak VK. Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512. PLoS One. 2012;7(11):e48787. doi: 10.1371/journal.pone.0048787. Epub 2012 Nov 30.

  PMID: 23226204 DERIVED

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Carboplatin; Paclitaxel; Sorafenib

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: SWOG Melanoma Statistician
• Organization: SWOG Statistical Office

206-667-4408

Study Officials

• Ana Aparicio

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 31, 2014
• Results First Posted: July 11, 2012

Record last verified: 2013-10

Locations

US (1)