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Completed

NCT Number: NCT00102505

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

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.

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Adenocarcinoma Adenocarcinoma of Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motexafin Gadolinium Injection

Drug

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

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
First posted
Jan 31, 2005
Registry last updated
Apr 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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