Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

NCT ID: NCT00120939

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Conditions

Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Motexafin Gadolinium

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gurkamal Chatta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PCYC-0212

Identifier Type: -

Identifier Source: org_study_id