Clinical trial NCT00373204: Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)
Official title: Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel
timeFrame: up to 12 cycles
Secondary outcomes:
measure: To estimate the time of progression
timeFrame: up to 12 cycles
measure: To estimate overall survival
timeFrame: up to 12 cycles
measure: To estimate progression-free survival
timeFrame: up to 12 cycles
measure: To estimate duration of response (CR + PR)
timeFrame: Up to 12 cycles
measure: To estimate clinical benefit rate (CR + PR + stable disease [SD])
timeFrame: up to 12 cycles
measure: To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC
timeFrame: Up to 12 cycles
Other outcomes:
Locations:
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Canton
country: United States
facility: Tri-County Hematology & Oncology Associates
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Chesapeake
country: United States
facility: Cancer Specialists of Tidewater
state: Virginia
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario
state: Ontario
city: Greenfield Park
country: Canada
facility: Hospital Charles Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center (Dept. of Chemotherapy)
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital
city: Moscow
country: Russian Federation
facility: Moscow Oncology Hospital #62
city: Samara
country: Russian Federation
facility: Samara Regional Oncology Center
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg City Oncology Center
city: Yaroslavl
country: Russian Federation
facility: Regional Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinic for Pulmonary Diseases, Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinic for Pulmonary Diseases
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
Study officials:
affiliation: University of Rochester, Rochester, NY, USA
name: Kishan Pandya, MD
role: STUDY_CHAIR
References: