Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Phase 1

Completed

• Conditions: Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

• Registration Number: NCT00120939
• Lead Sponsor: Pharmacyclics LLC.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-07-12
• Study First Submitted QC: 2005-07-12
• Study First Posted: 2005-07-19
• Status Verified: 2007-05
• Last Update Submitted: 2009-04-02
• Last Update Posted: 2009-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States