Carcinoma, Bronchogenic, Non-Small-Cell Lung Carcinoma
Conditions
Keywords
Non-Small Cell Lung Cancer, Lung Cancer, Metastatic lung cancer, Inoperable lung cancer, Advanced lung cancer, Large-cell lung cancer, Adenocarcinoma, lung, Squamous cell carcinoma, lung, Squamous cell lung cancer, Large cell carcinoma, lung, Bronchogenic
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.
Interventions
Sponsors
Pharmacyclics LLC.
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Kidneys * Liver and * Peripheral neuropathy Grade 2 or higher * Greater than 2 prior chemotherapy regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Tumor response | — |
Countries
United States
Outcome results
None listed