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

Primary Purpose

Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
bortezomib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ciliary Body and Choroid Melanoma, Medium/Large Size

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (bortezomib, paclitaxel, carboplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Time to disease progression
Estimated using the Kaplan-Meier method.
Duration of response
Estimated using the Kaplan-Meier method.
Survival time
Estimated using the Kaplan-Meier method.

Full Information

First Posted
February 6, 2006
Last Updated
March 4, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00288041
Brief Title
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
Official Title
A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
Detailed Description
PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVE: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Recurrent Intraocular Melanoma, Recurrent Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (bortezomib, paclitaxel, carboplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
bortezomib
Other Intervention Name(s)
LDP 341, MLN341, VELCADE
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Assessed up to 3 years
Title
Adverse event profile as measured by NCI-CAE version 3.0
Description
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.
Time Frame
Assessed up to 3 years
Secondary Outcome Measure Information:
Title
Time to disease progression
Description
Estimated using the Kaplan-Meier method.
Time Frame
From registration to documentation of disease progression, assessed up to 3 years
Title
Duration of response
Description
Estimated using the Kaplan-Meier method.
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
Title
Survival time
Description
Estimated using the Kaplan-Meier method.
Time Frame
From registration to death due to any cause, assessed up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Croghan
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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