Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non-Small-Cell Lung Carcinoma
- Sponsor
- Pharmacyclics LLC.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years old
- •ECOG score of 0, 1, or 2
- •Histologically confirmed diagnosis of non-small cell lung cancer
Exclusion Criteria
- •Laboratory values demonstrating inadequate function of the following:
- •Bone marrow
- •Peripheral neuropathy Grade 2 or higher
- •Greater than 2 prior chemotherapy regimens
Outcomes
Primary Outcomes
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 Outcomes
- Tumor response