A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small-Cell Lung CarcinomaCarcinoma, Bronchogenic
- Registration Number
- NCT00102505
- Lead Sponsor
- Pharmacyclics LLC.
- Brief Summary
The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- ≥ 18 years old
- ECOG score of 0, 1, or 2
- Histologically confirmed diagnosis of non-small cell lung cancer
Laboratory values demonstrating inadequate function of the following:
- Bone marrow
- Kidneys
- Liver
and
- Peripheral neuropathy Grade 2 or higher
- Greater than 2 prior chemotherapy regimens
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
- Secondary Outcome Measures
Name Time Method Tumor response
Trial Locations
- Locations (1)
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States