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Combination Paclitaxel, Carboplatin and Temozolomide

NCT00249964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-01-20

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.

Conditions

Interventions

DRUG

Combination Treatment - Cohort 1

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 75 mg/m2 per day from day 2 to day 6.

DRUG

Combination Treatment - Cohort 2

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 100 mg/m2 per day from day 2 to day 6.

DRUG

Combination Treatment - Cohort 3

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 125 mg/m2 per day from day 2 to day 6.

DRUG

Combination Treatment - Cohort 4

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 150 mg/m2 per day from day 2 to day 6.

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Fa-Chyi Lee, MD · University of New Mexico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00249964 on ClinicalTrials.gov