NCT00087191

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

July 8, 2004

Last Update Submit

January 15, 2013

Conditions

Advanced Adult Primary Liver CancerCarcinoma of the AppendixFallopian Tube CancerGastrointestinal Stromal TumorLocalized Extrahepatic Bile Duct CancerLocalized Gallbladder CancerLocalized Gastrointestinal Carcinoid TumorLocalized Resectable Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerMetastatic Gastrointestinal Carcinoid TumorOvarian SarcomaOvarian Stromal CancerPrimary Peritoneal Cavity CancerRecurrent Adult Primary Liver CancerRecurrent Adult Soft Tissue SarcomaRecurrent Colon CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerRecurrent Rectal CancerRecurrent Small Intestine CancerRecurrent Uterine SarcomaRegional Gastrointestinal Carcinoid TumorSmall Intestine AdenocarcinomaSmall Intestine LeiomyosarcomaSmall Intestine LymphomaStage 0 Non-small Cell Lung CancerStage I Adult Soft Tissue SarcomaStage I Colon CancerStage I Gastric CancerStage I Non-small Cell Lung CancerStage I Ovarian Epithelial CancerStage I Ovarian Germ Cell TumorStage I Pancreatic CancerStage I Rectal CancerStage I Uterine SarcomaStage II Adult Soft Tissue SarcomaStage II Colon CancerStage II Gastric CancerStage II Non-small Cell Lung CancerStage II Ovarian Epithelial CancerStage II Ovarian Germ Cell TumorStage II Pancreatic CancerStage II Rectal CancerStage II Uterine SarcomaStage III Adult Soft Tissue SarcomaStage III Colon CancerStage III Gastric CancerStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage III Pancreatic CancerStage III Rectal CancerStage III Uterine SarcomaStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Adult Soft Tissue SarcomaStage IV Colon CancerStage IV Gastric CancerStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic CancerStage IV Rectal CancerStage IV Uterine SarcomaUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder Cancer

Outcome Measures

Primary Outcomes (4)

  • Motexafin lutetium uptake in tumors and normal tissues

    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.

    At the time of surgery

  • Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue

    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.

    At the time of surgery

  • Pattern and presence of EF5 binding

    EF5 biding will be quantified.

    At the time of surgery

  • Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages.

    Up to 60 days following EF5 infusion

Study Arms (1)

Diagnostic (EF5, motexafin lutetium)

EXPERIMENTAL

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: EF5Drug: motexafin lutetiumOther: pharmacological study

Interventions

EF5DRUG

Given IV

Diagnostic (EF5, motexafin lutetium)
motexafin lutetiumDRUG

Given IV

Also known as: Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex, PCI-0123
Diagnostic (EF5, motexafin lutetium)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Diagnostic (EF5, motexafin lutetium)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Appendiceal NeoplasmsFallopian Tube NeoplasmsGastrointestinal Stromal TumorsCarcinoma, HepatocellularSarcomaColonic NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialPancreatic NeoplasmsRectal Neoplasms

Interventions

motexafin lutetium

Condition Hierarchy (Ancestors)

Cecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsLiver DiseasesColorectal NeoplasmsColonic DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesRectal Diseases

Study Officials

  • Stephen Michael Hahn

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

January 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)