Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer
Phase 1
Completed
- Conditions
- Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung NeoplasmsGastrointestinal 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
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