Study of the Effect on Non-Small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere) - Full Text View

Sponsored by:	Pharmacyclics
Information provided by:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT00373204

Purpose

The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: Motexafin Gadolinium	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Motexafin gadolinium Motexafin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Pharmacyclics:

Primary Outcome Measures:

To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered MGd and Docetaxel.

Secondary Outcome Measures:

To estimate the time to progression.
To estimate overall survival.
To estimate progression-free survival.
To estimate duration of response (CR + PR)
To estimate clinical benefit rate (CR + PR + stable disease).
To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC patients.

Estimated Enrollment:	61
Study Start Date:	May 2006
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.

Eligibility

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

Criteria

Inclusion Criteria:

≥ 18 years old
Histologically or cytologically confirmed diagnosis of NSCLC
Inoperable Stage IIIA, unresectable Stage IIIB or metastatic NSCLC patients who have received 1 prior platinum-based chemotherapy regimen
Measurable disease per RECIST
ECOG performance status score of 0 or 1
Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory values of: ANC < 1500/mm³, Platelet count < 100,000/mm³, hemoglobin < 10 g/dL, AST or ALT > 2.5 x upper limit of normal (ULN), Alkaline phosphatase > 5 x ULN, bilirubin > 1.5 x ULN, serum creatinine > 2.0 mg/dL (176 umol/dL), albumin < 3.0 g/dL (30 g/L)
Symptomatic or uncontrolled (untreated or treated and progressing) brain metastases
Evidence of meningeal metastasis
> 1 prior cytotoxic regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen, or prior MGd)
Chemotherapy, radiation therapy, experimental therapy, immunotherapy, or systemic biologic anticancer therapy within 21 days before beginning study treatment
Significant weight loss ≥ 10% of body weight within preceding 6 weeks
Treatment for another cancer within 3 years before enrollment, except basal cell carcinoma of the skin or cervical cancer in situ
Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association Class III or IV
Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy)
Known history of porphyria (testing not required at screening visit)
Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit)
History of hypersensitivity to taxanes or polysorbate 80
Known history of HIV infection (testing not required at screening visit)
Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential)
Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection
Physical or mental condition that makes patient unable to complete specified follow-up assessments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373204

Locations

United States, California
Wilshire Oncology Medical Group
La Verne, California, United States
United States, New York
University of Rochester
Rochester, New York, United States
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Tri-County Hematology & Oncology Associates
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
United States, Virginia
Cancer Specialists of Tidewater
Chesapeake, Virginia, United States
Canada, Ontario
Cancer Centre of Southeastern Ontario
Kingston, Ontario, Canada
Canada, Quebec
Hospital Charles Lemoyne
Greenfield Park, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Russian Federation
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk, Russian Federation
Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)
Moscow, Russian Federation
St. Petersburg City Oncology Center
St. Petersburg, Russian Federation
Moscow Oncology Hospital #62
Moscow, Russian Federation
Blokhin Cancer Research Center (Dept. of Chemotherapy)
Moscow, Russian Federation
Regional Oncology Dispensary
Yaroslavl, Russian Federation
Samara Regional Oncology Center
Samara, Russian Federation
Central Clinical Hospital
Moscow, Russian Federation
Serbia
Clinic for Pulmonary Diseases
Belgrade, Serbia
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica, Serbia
Clinic for Pulmonary Diseases, Military Medical Academy
Belgrade, Serbia

Sponsors and Collaborators

Pharmacyclics

Investigators

Study Chair:

Kishan Pandya, MD

University of Rochester, Rochester, NY, USA

More Information

Study ID Numbers:	PCYC-0229
Study First Received:	September 5, 2006
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00373204
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacyclics:

Advanced non-small cell lung cancer
Non-small cell lung cancer
Lung cancer
Metastatic lung cancer

Second line treatment for advanced lung cancer
Cancer
Advanced lung cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Motexafin gadolinium
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Photosensitizing Agents
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009