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CompletedNCT00102505Updated Apr 3, 2009

A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 interventional study of Motexafin Gadolinium Injection in Non-Small-Cell Lung Carcinoma and Carcinoma, Bronchogenic, sponsored by Pharmacyclics LLC.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-03.

Sponsored by Pharmacyclics LLC. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 36 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Pharmacyclics LLC. is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Masking
None (open label)
Enrollment
36 participants

Interventions

  • DrugMotexafin Gadolinium Injection
06

What researchers measure

Primary outcomes

  1. Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin

  2. Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin

Secondary outcomes

  1. Tumor response

07

Study locations

1 site
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00102505
Lead sponsor
Pharmacyclics LLC.
First posted
Jan 31, 2005
Start date
Nov 2004
Last update
Apr 3, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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