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Ciliary Body and Choroid Melanoma, Medium/Large SizePhase 2NCT00329641

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

A Phase 2 study testing carboplatin, paclitaxel and sorafenib tosylate in people with Ciliary Body and Choroid Melanoma, Medium/Large Size and Extraocular Extension Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboplatin, paclitaxel and sorafenib tosylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Feb 2011to Nov 2012
Phase
Phase 2
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

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwest Oncology Group

    San Antonio, Texas, 78245

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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 OBJECTIVES:

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

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.

Being tested
carboplatin, paclitaxel, sorafenib tosylate
Medical subject headings
Uveal Melanoma

What participants receive

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

Study groups in NCT00329641
Study groupRoleWhat they receive
Treatment (carboplatin, paclitaxel, sorafenib)ExperimentalPatients 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. ]
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: sorafenib tosylate

What is being measured

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

  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.

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

Secondary outcomes (3)

  1. One-year Overall Survival

    Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact

    Measured: 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

  2. 6-month Progression-free Survival

    Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact

    Measured: 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

  3. Toxicity

    Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

    Measured: Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 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 posted25 May 2006 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00329641
Sponsor's protocol ID
NCI-2009-00777
Other IDs
NCI-2009-00777, CDR0000467188, S0512, S0512, S0512, U10CA032102
Status last verified
Oct 2013
First submitted
23 May 2006
Last updated
31 Jul 2014

Publications

  • 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.

    PubMed 23226204

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, paclitaxel and sorafenib tosylate in people with Ciliary Body and Choroid Melanoma, Medium/Large Size and Extraocular Extension Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

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

Who may be eligible to take part?

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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Jul 2012). 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?

Response Rate (Complete and Partial Response) (time frame: Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression). 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 NCT00329641, 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 Jul 2014.

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