Non-Small-Cell Lung Carcinoma Clinical Trial
Official title:
Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
| NCT number | NCT00102505 |
| Other study ID # | PCYC-0220 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | January 29, 2005 |
| Last updated | April 2, 2009 |
| Start date | November 2004 |
| Verified date | April 2009 |
| Source | Pharmacyclics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmacyclics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin | |||
| Primary | Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin | |||
| Secondary | Tumor response |
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