Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

New Mexico Cancer Care Alliance

ClinicalTrials.gov Identifier:

NCT01009515

First received: October 14, 2009

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2009

Last Updated Date

March 14, 2013

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01009515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To determine median overall survival and median time to progression in the same population [ Time Frame: Until disease progression ] [ 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2015

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01009515

Other Study ID Numbers ^ICMJE

INST 0903, NCI-2011-01939

Has Data Monitoring Committee

Responsible Party

New Mexico Cancer Care Alliance

Study Sponsor ^ICMJE

New Mexico Cancer Care Alliance

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Montasur Shaheen, MD

University of New Mexico

Information Provided By

New Mexico Cancer Care Alliance

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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