Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Treatments: Motexafin gadolinium

Criteria

Inclusion Criteria:

• >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 Criteria:

• 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.