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

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.

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

Eligibility

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

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


Location and Contact Information

Cindy Cheng, PharmD      877-676-0330    medicalaffairs@pcyc.com

Texas
      The University of Texas MD Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Rainelle Schaere  713-745-5912    rschaere@mdanderson.org 
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
ClinicalTrials.gov Identifier:  NCT00102505
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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