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Ciliary Body and Choroid Melanoma, Medium/Large SizePhase 2NCT00288041

Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma

A Phase 2 study testing carboplatin, paclitaxel and bortezomib 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 giving bortezomib together with paclitaxel and carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboplatin, paclitaxel and bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Oct 2005to Sep 2007
Phase
Phase 2
Are there results?
None posted in the registry

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:

  • No uncontrolled intercurrent illness including any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia
  • No psychiatric illness that would limit compliance with study requirements
  • No other uncontrolled serious medical conditions (e.g., diabetes)
  • No more than 1 prior cytotoxic chemotherapy regimen
  • No more than 2 prior immunotherapy regimens either in adjuvant or metastatic setting
  • At least 4 weeks since prior major radiotherapy or chemotherapy
  • At least 8 weeks since prior monoclonal antibody therapy
  • At least 4 weeks since prior immunotherapy or biologic therapy
  • At least 3 weeks since prior surgery
  • Recovered from prior therapies
  • No prior therapy with bortezomib, paclitaxel, or carboplatin
  • No other prior or concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent prophylactic colony-stimulating factors
  • Histologically confirmed malignant melanoma
  • Patients with significant fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the principal investigator
  • No known brain metastases by brain imaging with contrast
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Routine urine analysis with predicted 24-hour urine protein < 500 mg OR 1+ proteinuria by urine dipstick with 24-hour urine protein < 500 mg
  • Total bilirubin < 1.5 mg/dL
  • AST =< 3 times ULN
  • Creatinine =< 1.5 times ULN
  • ECOG performance status (PS) 0, 1, or 2 (Karnofsky PS >= 60%)
  • Life expectancy by physician estimate > 12 weeks
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Negative pregnancy test
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib
  • No peripheral neuropathy >= grade 2
  • Manifestations of stage IV disease (e.g., cutaneous, uveal)
  • All melanomas, regardless of origin, allowed
  • Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral CT scan
  • No nonmeasurable disease only, including any of the following: bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, cystic lesions
  • Hemoglobin >= 9.0 g/dL

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma

This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may help paclitaxel and carboplatin kill more tumor cells by making tumor cells more sensitive to these drugs

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the confirmed tumor response rate and adverse event profile of bortezomib, carboplatin, and paclitaxel as first-line therapy for patients with metastatic melanoma.

SECONDARY OBJECTIVE:

  1. Evaluate time to tumor progression, overall survival, and duration of response.

OUTLINE: This is a multicenter study.

Patients receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

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

Medical subject headings
Uveal Melanoma, Melanoma

What participants receive

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

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given IV

Study groups in NCT00288041
Study groupRoleWhat they receive
Treatment (bortezomib, paclitaxel, carboplatin)ExperimentalPatients will receive an infusion of bortezomib twice in week 1 and once in week 2. They will also receive a 3-hour infusion of paclitaxel and an infusion of carboplatin once in week 1. Treatment may repeat every 3 weeks for as long as benefit is shown.
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: bortezomib

What is being measured

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

  1. Confirmed tumor response rate defined as the total number of evaluable patients whose objective tumor status is either a complete or partial response according to the RECIST criteria

    If at most 3 of the first 19 eligible patients enrolled achieved a partial or complete response by the RECIST criteria, then enrollment would be terminated and the regimen would be considered inactive in this patient population. A 90% confidence interval will be constructed using the Duffy-Santer approach.

    Measured: Assessed up to 3 years

  2. Adverse event profile as measured by NCI-CAE version 3.0

    The maximum grade for each type of toxicity will be recorded for each patient at each evaluation. The frequency and severity of each type of toxicity will be determined overall and by course.

    Measured: Assessed up to 3 years

Secondary outcomes (3)

  1. Time to disease progression

    Estimated using the Kaplan-Meier method.

    Measured: From registration to documentation of disease progression, assessed up to 3 years

  2. Duration of response

    Estimated using the Kaplan-Meier method.

    Measured: From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years

  3. Survival time

    Estimated using the Kaplan-Meier method.

    Measured: From registration to death due to any cause, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionSep 2007

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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288041
Sponsor's protocol ID
NCI-2009-00138
Other IDs
MC047C, N01CM62205
Status last verified
Mar 2013
First submitted
6 Feb 2006
Last updated
5 Mar 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, paclitaxel and bortezomib 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 5 Mar 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Confirmed tumor response rate defined as the total number of evaluable patients whose objective tumor status is either a complete or partial response according to the RECIST criteria (time frame: Assessed up to 3 years). The study lists 2 primary outcomes in all. 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 NCT00288041.

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 5 Mar 2013.

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