Recurrent Melanoma Clinical Trial
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
Status | Completed |
Enrollment | 36 |
Est. completion date | |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | Yes |
Secondary | Time to disease progression | Estimated using the Kaplan-Meier method. | From registration to documentation of disease progression, assessed up to 3 years | No |
Secondary | Duration of response | Estimated using the Kaplan-Meier method. | 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 | No |
Secondary | Survival time | Estimated using the Kaplan-Meier method. | From registration to death due to any cause, assessed up to 3 years | No |
Status | Clinical Trial | Phase | |
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