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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087191 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention |
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Cancer |
Drug: EF5 Drug: motexafin lutetium |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies |
Study Start Date: | May 2004 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed or suspected diagnosis of 1 of the following:
Intra-abdominal malignancy of 1 of the following types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Stephen Michael Hahn, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000373812, UPCC-04204, NCI-6508 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00087191 History of Changes |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage I ovarian epithelial cancer stage I ovarian germ cell tumor stage II ovarian epithelial cancer stage II ovarian germ cell tumor stage III ovarian epithelial cancer stage III ovarian germ cell tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor carcinoma of the appendix recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer |
localized gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastric cancer recurrent gastrointestinal carcinoid tumor stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer recurrent adult soft tissue sarcoma recurrent uterine sarcoma stage I adult soft tissue sarcoma stage I uterine sarcoma stage II adult soft tissue sarcoma stage II uterine sarcoma stage III adult soft tissue sarcoma |
Thoracic Neoplasms Fallopian Tube Cancer Rectal Neoplasms Leiomyosarcoma Pancreatic Neoplasms Bile Duct Cancer, Extrahepatic Liver Neoplasms Soft Tissue Sarcomas Respiratory Tract Diseases Lung Neoplasms Stomach Neoplasms Motexafin lutetium Lymphoma Rectal Neoplasm Ovarian Epithelial Cancer |
Fallopian Tube Neoplasms Recurrence Carcinoma Gall Bladder Cancer Photosensitizing Agents Malignant Mesenchymal Tumor Rectal Cancer Radiation-Sensitizing Agents Uterine Sarcoma Lung Diseases Sarcoma Non-small Cell Lung Cancer Carcinoid Tumor Stomach Cancer Gallbladder Neoplasms |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Physiological Effects of Drugs Pharmacologic Actions Carcinoma Neoplasms Photosensitizing Agents Neoplasms by Site |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Dermatologic Agents Carcinoma, Non-Small-Cell Lung Motexafin lutetium Neoplasms, Glandular and Epithelial |