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

This study is currently recruiting patients.

Sponsored by: Pharmacyclics
Information provided by: Pharmacyclics


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 Treatment or Intervention Phase
Non-Small-Cell Lung Carcinoma
Carcinoma, Bronchogenic
 Drug: Motexafin Gadolinium Injection
Phase I

MedlinePlus related topics:  Cancer;   Lung Cancer

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)

Further Study Details: 

Expected Total Enrollment:  36

Study start: November 2004


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both


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


Location and Contact Information

Cindy Cheng, PharmD      877-676-0330

      The University of Texas MD Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Rainelle Schaere  713-745-5912 
David Stewart, MD,  Principal Investigator

More Information

Study ID Numbers:  PCYC-0220
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  January 29, 2005 Identifier:  NCT00102505
Health Authority: United States: Food and Drug Administration processed this record on 2005-04-08

Cache Date: April 9, 2005