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

This study has been completed.
Information provided by:
Pharmacyclics LLC. Identifier:
First received: January 29, 2005
Last updated: April 2, 2009
Last verified: April 2009

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
Carcinoma, Bronchogenic
Drug: Motexafin Gadolinium Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Pharmacyclics LLC.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Tumor response

Estimated Enrollment: 36
Study Start Date: November 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

Laboratory values demonstrating inadequate function of the following:

  • Bone marrow
  • Kidneys
  • Liver


  • Peripheral neuropathy Grade 2 or higher
  • Greater than 2 prior chemotherapy regimens
  Contacts and Locations
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Please refer to this study by its identifier: NCT00102505

United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pharmacyclics LLC.
  More Information Identifier: NCT00102505     History of Changes
Other Study ID Numbers: PCYC-0220
Study First Received: January 29, 2005
Last Updated: April 2, 2009

Keywords provided by Pharmacyclics LLC.:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bronchial Neoplasms
Motexafin gadolinium
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Dermatologic Agents processed this record on May 25, 2017