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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.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00102505
First received: January 29, 2005
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  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 Intervention Phase
Non-Small-Cell Lung Carcinoma
Carcinoma, Bronchogenic
 Drug: Motexafin Gadolinium Injection
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Pharmacyclics:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

Locations
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pharmacyclics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102505     History of Changes
Other Study ID Numbers: PCYC-0220
Study First Received: January 29, 2005
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Docetaxel
Motexafin gadolinium
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013