Ovarian Cancer Clinical Trial
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Summary
This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy
Full Description
OBJECTIVES:
I. Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with intra-abdominal malignancies or non-small cell lung cancer.
II. Determine the ratio of tumor to normal tissue by measuring the level of motexafin lutetium uptake in tumor and normal tissue removed from these patients.
III. Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for hypoxia) in tumors of these patients.
IV. Determine the feasibility of measuring optical properties, tissue oxygenation, motexafin lutetium concentration, fluorescence, and blood flow by non-invasive means in these patients.
OUTLINE: This is a multicenter, diagnostic study. Patients are stratified according to diagnosis (intra-abdominal malignancy vs non-small cell lung cancer).
Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.
After completion of study treatment, patients are followed at approximately 1-8 weeks.
PROJECTED ACCRUAL: A total of 30 patients (20 with intra-abdominal malignancies and 10 with non-small cell lung cancer) will be accrued for this study within 10-15 months.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed or suspected diagnosis of 1 of the following:
Intra-abdominal malignancy of 1 of the following types:
Sarcoma
Ovarian cancer
Gastrointestinal malignancies, including, but not limited to, appendiceal cancer, colon cancer, or gastric cancer
Non-small cell lung cancer
Planning to undergo surgical resection of disease
Disease has the propensity to spread to the peritoneal cavity (intra-abdominal malignancy patients)
Performance status - ECOG 0-2
WBC ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin < 1.5 mg/dL
Creatinine normal
Creatinine clearance ≥ 60 mL/min
Body weight ≤ 130 kg
No G6PD deficiency
No porphyria
No history of peripheral neuropathy ≥ grade 3
Able to tolerate anesthesia and major surgery
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study participation
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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