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

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ClinicalTrials.gov Identifier: NCT00087191
Recruitment Status : Terminated (Administratively complete.)
First Posted : July 12, 2004
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 8, 2004
First Posted Date  ICMJE July 12, 2004
Last Update Posted Date January 16, 2013
Study Start Date  ICMJE May 2004
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00087191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Official Title  ICMJE Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
Brief 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: EF5
  • Drug: motexafin lutetium
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2013)
30
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00087191
Other Study ID Numbers  ICMJE NCI-2012-02607
UPCC# 04204
P01CA087971 ( U.S. NIH Grant/Contract )
CDR0000373812 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Michael Hahn Abramson Cancer Center of the University of Pennsylvania
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP