Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

New Mexico Cancer Care Alliance

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Drug: Paclitaxel, carboplatin, temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01009515

NCI-2011-01939 (Registry Identifier)

INST 0903

Details and patient eligibility

About

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.

Full description

Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Chemotherapy Combination

Experimental group

Description:

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Treatment:

Drug: Paclitaxel, carboplatin, temozolomide