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| Sponsored by: |
Pharmacyclics |
|---|---|
| Information provided by: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00102505 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Carcinoma Carcinoma, Bronchogenic |
Drug: Motexafin Gadolinium Injection |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study |
| Official Title: | Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC) |
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory values demonstrating inadequate function of the following:
and
Contacts and Locations More Information
| Study ID Numbers: | PCYC-0220 |
| Study First Received: | January 29, 2005 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00102505 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Thoracic Neoplasms Motexafin gadolinium Squamous Cell Carcinoma Carcinoma Docetaxel Photosensitizing Agents Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Large Cell Epidermoid Carcinoma Non-small Cell Lung Cancer Carcinoma, Squamous Cell Adenocarcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Motexafin gadolinium Pharmacologic Actions Carcinoma Photosensitizing Agents Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Bronchogenic Dermatologic Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
