Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Stopped early · Phase 2

Conditions studied: Melanoma

In brief

The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Key facts

Study ID

NCT01009515

Run by

New Mexico Cancer Research Alliance

People needed

19

Starts

2009-08-01

Expected to finish

2015-06-01

Last updated by the study team

2017-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients with biopsy proven advanced melanoma are eligible if there is measurable disease.
• Patients must have a life expectancy of at least 12 weeks.
• Prior surgery, immunotherapy, minimal chemotherapy (1 drug for less than 4 months), or radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks from study entry, and patient should have completely recovered from such procedures.
• Patients must have a Zubrod performance status of 0-2.
• Patients must sign an informed consent.
• Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1500 cells/mm3, hemoglobin > 8 g/dl, platelet count ≥ 100 000/mm3.
• Patients should have a normal hepatic function with a total bilirubin < 1.5 the upper limit of normal (ULN) and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) < 2 times the upper limit of normal (ULN),and adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and at least for 3 months.
• Patients with brain metastases are eligible if they have been appropriately treated, are asymptomatic

You may not qualify if…

• Pregnant women or nursing mothers are not eligible.
• Patients must not receive any other concurrent chemotherapy or radiation during this trial.
• Patients with severe medical problems that would interfere with the therapy are not eligible.

Where it is running

• Hematology Oncology Associates — Albuquerque, New Mexico, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• The Cancer Center at Presbyterian — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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