EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer

Stopped early · Not applicable

Conditions studied: Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer, Localized Gastrointestinal Carcinoid Tumor, Localized Resectable Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Metastatic Gastrointestinal Carcinoid Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Primary Peritoneal Cavity Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Adult Soft Tissue Sarcoma, Recurrent Colon Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Small Intestine Cancer, Recurrent Uterine Sarcoma, Regional Gastrointestinal Carcinoid Tumor, Small Intestine Adenocarcinoma, Small Intestine Leiomyosarcoma, Small Intestine Lymphoma, Stage 0 Non-small Cell Lung Cancer, Stage I Adult Soft Tissue Sarcoma, Stage I Colon Cancer, Stage I Gastric Cancer, Stage I Non-small Cell Lung Cancer, Stage I Ovarian Epithelial Cancer, Stage I Ovarian Germ Cell Tumor, Stage I Pancreatic Cancer, Stage I Rectal Cancer, Stage I Uterine Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage II Colon Cancer, Stage II Gastric Cancer, Stage II Non-small Cell Lung Cancer, Stage II Ovarian Epithelial Cancer, Stage II Ovarian Germ Cell Tumor, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage II Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Uterine Sarcoma, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Adult Soft Tissue Sarcoma, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Uterine Sarcoma, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

In brief

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

Key facts

Study ID

NCT00087191

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2004-05-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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