Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ciliary Body and Choroid Melanoma, Medium/Large Size | Medium/Large Size Posterior Uveal Melanoma | ALIAS | 0.90 |
| Extraocular Extension Melanoma | Ocular Melanoma with Extraocular Extension | ALIAS | 0.90 |
| Iris Melanoma | Iris Melanoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Intraocular Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib, paclitaxel, carboplatin)
- 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.
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Drug: bortezomib
Primary outcomes (2)
- measure
- 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
- timeFrame
- Assessed up to 3 years
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available