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

NCT00288041 | Completed Phase 2

• 3 other identifiers: NCI-2009-00138MC047CN01CM62205
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed up to 3 years

• 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.

  Assessed up to 3 years

Secondary Outcomes (3)

• Time to disease progression

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

• Duration of response

  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

• Survival time

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

Study Arms (1)

Treatment (bortezomib, paclitaxel, carboplatin)

EXPERIMENTAL

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; Drug: paclitaxel; Drug: bortezomib

Interventions

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (bortezomib, paclitaxel, carboplatin)

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Treatment (bortezomib, paclitaxel, carboplatin)

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib, paclitaxel, carboplatin)

Eligibility Criteria

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

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

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)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

Carboplatin; Paclitaxel; Taxes; Bortezomib

Condition Hierarchy (Ancestors)

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; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gary Croghan

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: February 6, 2006
• First Posted: February 7, 2006
• Study Start: October 1, 2005
• Primary Completion: September 1, 2007
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

US (1)