Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
NCT ID: NCT00129844
Last Updated: 2008-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2005-09-30
2007-12-31
Brief Summary
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Detailed Description
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Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:
Arm A - 10 mg/kg MGd once per week
Arm B - 15 mg/kg MGd once every 3 weeks
Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.
At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Motexafin Gadolinium
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of NSCLC
* Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* ECOG performance status score of 0 or 1
* Willing and able to provide written informed consent
Exclusion Criteria
* Absolute neutrophil count \< 1500/ul;
* Platelet count \< 75,000/ul;
* Hemoglobin \< 10 gm/dl;
* AST or ALT \> 3 x the upper limit of normal (ULN);
* Alkaline phosphatase \> 5 x ULN;
* Bilirubin \> 2 x ULN;
* Serum creatinine \> 2.0 mg/dL.
* Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
* Evidence of meningeal metastasis.
* Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed \> 12 months prior to cytotoxic regimen).
* 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 in preceding 6 weeks.
* Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ.
* Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) 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).
* 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.
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Principal Investigators
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Robert Natale, M.D.
Role: STUDY_CHAIR
Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center
Locations
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Fountain Valley, California, United States
Los Angeles, California, United States
Palm Springs, California, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Akron, Ohio, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Countries
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Other Identifiers
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PCYC-0227
Identifier Type: -
Identifier Source: org_study_id