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EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
This study has been completed.
Sponsors and Collaborators: University of Pennsylvania
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087191
  Purpose

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
Cancer
Drug: EF5
Drug: motexafin lutetium

MedlinePlus related topics: Cancer Carcinoid Tumors Gallbladder Cancer Liver Cancer Lung Cancer Pancreatic Cancer Soft Tissue Sarcoma Stomach Cancer
Drug Information available for: Motexafin Motexafin lutetium
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label
Official Title: Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2004
Detailed Description:

OBJECTIVES:

  • Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with intra-abdominal malignancies or non-small cell lung cancer.
  • 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.
  • Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for hypoxia) in tumors of these patients.
  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 mg/dL

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087191

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Stephen Michael Hahn, MD University of Pennsylvania
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000373812, UPCC-04204, NCI-6508
Study First Received: July 8, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00087191  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Rectal Neoplasms
Leiomyosarcoma
Pancreatic Neoplasms
Malignant mesenchymal tumor
Liver neoplasms
Ovarian epithelial cancer
Dental Caries
Soft tissue sarcomas
Liver Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Stomach Neoplasms
Motexafin lutetium
Rectal cancer
Lymphoma
Bile duct cancer, extrahepatic
Non-small cell lung cancer
Stomach cancer
Fallopian Tube Neoplasms
Recurrence
Gall bladder cancer
Rectal neoplasm
Carcinoma
Carcinoid tumor
Lung Diseases
Sarcoma
Uterine sarcoma
Carcinoid Tumor
Gallbladder Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Photosensitizing Agents
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009