NCT00102505

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2005

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

First QC Date

January 29, 2005

Last Update Submit

April 2, 2009

Conditions

Non-Small-Cell Lung CarcinomaCarcinoma, Bronchogenic

Keywords

Non-Small Cell Lung CancerLung CancerMetastatic lung cancerInoperable lung cancerAdvanced lung cancerLarge-cell lung cancerAdenocarcinoma, lungSquamous cell carcinoma, lungSquamous cell lung cancerLarge cell carcinoma, lungBronchogenic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Tumor response

Interventions

Motexafin Gadolinium InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • ECOG score of 0, 1, or 2
  • Histologically confirmed diagnosis of non-small cell lung cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, BronchogenicLung NeoplasmsAdenocarcinoma of LungCarcinoma, Squamous CellCarcinoma, Large Cell

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 29, 2005

First Posted

January 31, 2005

Study Start

November 1, 2004

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

US(1)