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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 terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087191
First received: July 8, 2004
Last updated: January 15, 2013
Last verified: January 2013
  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. 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

Condition Intervention
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 Drug: EF5 Drug: motexafin lutetium Other: pharmacological study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Motexafin lutetium uptake in tumors and normal tissues [ Time Frame: At the time of surgery ]
    Data will be described using graphical techniques (e.g., box plots) and summary statistics (e.g., means, medians, standard deviations, and interquartile ranges). For each patient, the mean concentration of motexafin lutetium across tumor and normal samples will be summarized.

  • Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue [ Time Frame: At the time of surgery ]
    Summary data for each patient will be used to construct a TNTR. Wilcoxon signed rank test of whether the median ration exceeds will be carried out.

  • Pattern and presence of EF5 binding [ Time Frame: At the time of surgery ]
    EF5 biding will be quantified.

  • Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 60 days following EF5 infusion ]
    Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages.


Enrollment: 30
Study Start Date: May 2004
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (EF5, motexafin lutetium)
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.
Drug: EF5
Given IV
Drug: motexafin lutetium
Given IV
Other Names:
  • Antrin
  • lutetium texaphrin
  • lutetium texaphyrin
  • Lutex
  • PCI-0123
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Michael Hahn Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087191     History of Changes
Other Study ID Numbers: NCI-2012-02607
UPCC# 04204
P01CA087971 ( U.S. NIH Grant/Contract )
CDR0000373812 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: July 8, 2004
Last Updated: January 15, 2013

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplasms
Lung Neoplasms
Adenocarcinoma
Pancreatic Neoplasms
Sarcoma
Stomach Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Gastrointestinal Stromal Tumors
Germinoma
Carcinoid Tumor
Gallbladder Neoplasms
Neuroendocrine Tumors
Bile Duct Neoplasms
Cholangiocarcinoma
Leiomyosarcoma
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Intestinal Neoplasms
Appendiceal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases

ClinicalTrials.gov processed this record on July 19, 2017