- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288041
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Assessed up to 3 years
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Adverse event profile as measured by NCI-CAE version 3.0
Time Frame: Assessed up to 3 years
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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.
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Assessed up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to disease progression
Time Frame: From registration to documentation of disease progression, assessed up to 3 years
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Estimated using the Kaplan-Meier method.
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From registration to documentation of disease progression, assessed up to 3 years
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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
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Estimated using the Kaplan-Meier method.
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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
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Survival time
Time Frame: From registration to death due to any cause, assessed up to 3 years
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Estimated using the Kaplan-Meier method.
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From registration to death due to any cause, assessed up to 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary Croghan, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Recurrence
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Bortezomib
Other Study ID Numbers
- NCI-2009-00138
- N01CM62205 (U.S. NIH Grant/Contract)
- MC047C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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