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

Stopped early · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00373204

Run by

Pharmacyclics LLC.

People needed

50

Starts

2006-05-01

Expected to finish

2008-05-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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