Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2013
• Main ID: NCT00288041
• Date of registration: 06/02/2006
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
• Scientific title: A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
• Date of first enrolment: October 2005
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00288041
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Gary Croghan
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ciliary Body and Choroid Melanoma, Medium/Large Size

Extraocular Extension Melanoma

Iris Melanoma

Recurrent Intraocular Melanoma

Recurrent Melanoma

Stage IV Melanoma

Intervention(s)

Drug: bortezomib

Drug: carboplatin

Drug: paclitaxel

Primary Outcome(s)

Adverse event profile as measured by NCI-CAE version 3.0 [Time Frame: Assessed up to 3 years]

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]

Secondary Outcome(s)

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]

Survival time [Time Frame: From registration to death due to any cause, assessed up to 3 years]

Time to disease progression [Time Frame: From registration to documentation of disease progression, assessed up to 3 years]

Secondary ID(s)

MC047C

N01CM62205

NCI-2009-00138

Source(s) of Monetary Support

Please refer to primary and secondary sponsors