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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
N/A
Not Enrolling
Both
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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Gary Croghan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00138

NCT ID:

NCT00288041

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

Name

Location

Mayo ClinicRochester, Minnesota  55905