Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma - Full Text View

Purpose

The primary objective of this study is to determine the objective response rate of a combination drug treatment including carboplatin, paclitaxel and temozolomide in the treatment of metastatic or recurrent melanoma.

Condition	Intervention	Phase
Melanoma	Drug: paclitaxel, carboplatin, temozolomide	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Paclitaxel Carboplatin Temozolomide

Genetic and Rare Diseases Information Center resources: APUDoma Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:

To determine the objective response rate for the combination of carboplatin, paclitaxel and temozolomide in the treatment of metastatic or recurrent melanoma. [ Time Frame: 6months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine median overall survival and median time to progression in the same population [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To determine safety profile and major adverse events for this combination. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	50
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2015
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Chemotherapy Combination Treatment with 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.	Drug: paclitaxel, carboplatin, temozolomide Carboplatin at an AUC of 5 on D1, paclitaxel at 175 mg/m2 on D1, temozolomide at 125 mg/m2 D2-D6 on a 28 day cycle.

Detailed Description:

Carboplatin at a dose determinated by AUC equal to 5 on Day 1, and
Paclitaxel at 175 mg/m2 on Day 1, and
Temozolomide at 125 mg/m2 on Days 2 through 6 on a 28 day cycle.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 trial.
Patients with severe medical problems that would interfere with the therapy are not eligible.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009515

Locations


United States, New Mexico
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
The Cancer Center at Presbyterian
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106

Sponsors and Collaborators

New Mexico Cancer Care Alliance

Investigators


Principal Investigator:	Montasur Shaheen, MD	University of New Mexico

More Information

Additional Information:

University of New Mexico Cancer Center This link exits the ClinicalTrials.gov site

New Mexico Cancer Care Alliance This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT01009515 History of Changes
Other Study ID Numbers:	INST 0903, NCI-2011-01939
Study First Received:	October 14, 2009
Last Updated:	March 3, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:


metastatic melanoma skin cancer

Additional relevant MeSH terms:


Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Carboplatin Paclitaxel Temozolomide	Alkylating Agents Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators

ClinicalTrials.gov processed this record on March 03, 2015