Back to resultsA Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-Small-Cell Lung Carcinoma, Carcinoma, Bronchogenic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motexafin Gadolinium Injection
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring 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
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 Kidneys Liver and Peripheral neuropathy Grade 2 or higher Greater than 2 prior chemotherapy regimens
Sites / Locations
- The University of Texas MD Anderson Cancer Center
Outcomes
Primary Outcome Measures
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
Tumor response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102505
Brief Title
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Official Title
Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma, Carcinoma, Bronchogenic
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium Injection
Primary Outcome Measure Information:
Title
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Title
Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
Secondary Outcome Measure Information:
Title
Tumor response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Kidneys
Liver
and
Peripheral neuropathy Grade 2 or higher
Greater than 2 prior chemotherapy regimens
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
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