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Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

NCT ID: NCT01009515

Last Updated: 2017-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma

Keywords

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metastatic melanoma skin cancer paclitaxel carboplatin temozolomide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy Combination

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.

Group Type EXPERIMENTAL

Paclitaxel, carboplatin, temozolomide

Intervention Type DRUG

Combination chemotherapy was administered for up to 6 cycles

Interventions

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Paclitaxel, carboplatin, temozolomide

Combination chemotherapy was administered for up to 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Montasur Shaheen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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Hematology Oncology Associates

Albuquerque, New Mexico, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

The Cancer Center at Presbyterian

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Related Links

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http://www.cancer.unm.edu

University of New Mexico Cancer Center

http://www.nmcca.org

New Mexico Cancer Care Alliance

Other Identifiers

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NCI-2011-01939

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 0903

Identifier Type: -

Identifier Source: org_study_id