Expired Study
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Houston, Texas 77030


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.


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


Study is Available At:


Original ID:

PCYC-0220


NCT ID:

NCT00102505


Secondary ID:


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pharmacyclics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:


Study Dates

Start Date:November 2004
Verification Date:April 2009
Last Changed Date:April 2, 2009
First Received Date:January 29, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tumor response
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Motexafin Gadolinium Injection

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pharmacyclics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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