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A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Recurrent Intraocular Melanoma, Recurrent Melanoma, Stage IV Melanoma

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Trial Information

A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma


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.


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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome 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.

Outcome Time Frame:

Assessed up to 3 years

Safety Issue:


Principal Investigator

Gary Croghan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

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



Mayo Clinic Rochester, Minnesota  55905