Status:
COMPLETED
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Adenocarcinoma
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.
Detailed Description
Outline: 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 on...
Eligibility Criteria
Inclusion
- \>18 years old
- 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
- Laboratory values of:
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00129844
Start Date
September 1 2005
End Date
December 1 2007
Last Update
August 20 2008
Active Locations (16)
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1
Fountain Valley, California, United States
2
Los Angeles, California, United States
3
Palm Springs, California, United States
4
Columbia, Missouri, United States