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Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00120939
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pharmacyclics LLC.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Gurkamal Chatta, MD
Principal Investigator Affiliation University of Pittsburgh Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

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