Study Of Motexafin Gadolinium And Docetaxel For Advanced Cancer

Study Overview

Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.

N/A

Breast Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms

DRUG: Motexafin Gadolinium

PCYC-0212

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-07-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-04-02
First Submitted that Met QC Criteria 2005-07-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-04-03
First Posted (ESTIMATED) 2005-07-19	Results First Posted N/A	Last Verified 2007-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Outcome Measures	Measure Description	Time Frame
Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

At least 18 years old
Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
ECOG performance status score either 0, 1, or 2
Willing and able to provide written informed consent

Greater than two prior cytotoxic regimens
Laboratory values showing adequate function of bone marrow, liver, and kidneys
Uncontrolled hypertension
Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Gurkamal Chatta, MD, University of Pittsburgh Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record