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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288041
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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. 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

Condition or disease Intervention/treatment Phase
Ciliary Body and Choroid Melanoma, Medium/Large Size Extraocular Extension Melanoma Iris Melanoma Recurrent Intraocular Melanoma Recurrent Melanoma Stage IV Melanoma Drug: carboplatin Drug: paclitaxel Drug: bortezomib Phase 2

Detailed Description:


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


I. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
Study Start Date : October 2005
Actual Primary Completion Date : September 2007

Arm Intervention/treatment
Experimental: Treatment (bortezomib, paclitaxel, carboplatin)
Patients 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.
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • JM-8
  • Paraplat
  • Paraplatin

Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341

Primary Outcome Measures :
  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 [ Time Frame: Assessed up to 3 years ]
    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.

  2. Adverse event profile as measured by NCI-CAE version 3.0 [ Time Frame: Assessed up to 3 years ]
    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.

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: From registration to documentation of disease progression, assessed up to 3 years ]
    Estimated using the Kaplan-Meier method.

  2. Duration of response [ Time Frame: 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 ]
    Estimated using the Kaplan-Meier method.

  3. Survival time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ]
    Estimated using the Kaplan-Meier method.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00288041

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Gary Croghan Mayo Clinic
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00288041    
Other Study ID Numbers: NCI-2009-00138
N01CM62205 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action