Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)
- Registration Number
- NCT00373204
- Lead Sponsor
- Pharmacyclics LLC.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Xcytrin® (motexafin gadolinium) Motexafin Gadolinium -
- Primary Outcome Measures
Name Time Method To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel up to 12 cycles The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
- Secondary Outcome Measures
Name Time Method To estimate the time of progression up to 12 cycles The progression is defined as the time fromfirst does of MGd to first eviedence of progression
To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC Up to 12 cycles All patients who receive at one dose of MGd will be included in the safety summaries and analyses
To estimate overall survival up to 12 cycles The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel
To estimate progression-free survival up to 12 cycles Progression-free survival is defined as the time from first does of MGd to the earlier of progression
To estimate duration of response (CR + PR) Up to 12 cycles Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.
To estimate clinical benefit rate (CR + PR + stable disease [SD]) up to 12 cycles The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation
Trial Locations
- Locations (22)
Wilshire Oncology Medical Group
🇺🇸La Verne, California, United States
University of Rochester
🇺🇸Rochester, New York, United States
Clinic for Pulmonary Diseases
🇷🇸Belgrade, Serbia
Institute for Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Chelyabinsk Regional Oncology Dispensary
🇷🇺Chelyabinsk, Russian Federation
St. Petersburg City Oncology Center
🇷🇺St. Petersburg, Russian Federation
Institute for Pulmonary Diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia
Moscow Oncology Hospital #62
🇷🇺Moscow, Russian Federation
Regional Oncology Dispensary
🇷🇺Yaroslavl, Russian Federation
Clinic for Pulmonary Diseases, Military Medical Academy
🇷🇸Belgrade, Serbia
Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)
🇷🇺Moscow, Russian Federation
Central Clinical Hospital
🇷🇺Moscow, Russian Federation
Samara Regional Oncology Center
🇷🇺Samara, Russian Federation
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Cancer Specialists of Tidewater
🇺🇸Chesapeake, Virginia, United States
Pennsylvania Oncology Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Centre of Southeastern Ontario
🇨🇦Kingston, Ontario, Canada
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Hospital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Tri-County Hematology & Oncology Associates
🇺🇸Canton, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Blokhin Cancer Research Center (Dept. of Chemotherapy)
🇷🇺Moscow, Russian Federation