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Phase II of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase II of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Inclusion Criteria:

- All patients with biopsy proven advanced melanoma are eligible if there is measurable

- 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

- 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

- Patients should have a normal hepatic function with a total bilirubin < 1.5 the
upper limit of normal and SGOT or SGPT < 2 times the upper limit of normal, and
adequate renal function as defined by a serum creatinine ≤ 1.5 upper limit of normal

- 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

- Patients with severe medical problems that would interfere with the therapy are not

Type of Study:


Study Design:

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

Outcome Measure:

To determine the objective response rate for the combination of carboplatin, paclitaxel and temozolomide in the treatment of metastatic or recurrent melanoma.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Montasur Shaheen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:

INST 0903



Start Date:

August 2009

Completion Date:

August 2015

Related Keywords:

  • Melanoma
  • metastatic
  • melanoma
  • Melanoma



University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Hematology Oncology Associates Albuquerque, New Mexico  87106
The Cancer Center at Presbyterian Albuquerque, New Mexico  87110