A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Study Identifier
PCYC-0220
CT.gov Identifier
NCT00102505
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Lung Cancer - Non-Small Cell Lung Cancer (NSCLC)
    • Study Drug
  • Motexafin Gadolinium Injection
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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 * Kidneys * Liver and * Peripheral neuropathy Grade 2 or higher * Greater than 2 prior chemotherapy regimens

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States, 77030
    Status
    Not applicable