Advanced Adult Primary Liver CancerNCT00087191

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

A study testing EF5, motexafin lutetium and pharmacological study in people with Advanced Adult Primary Liver Cancer and Carcinoma of the Appendix, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer
What is being tested?: EF5, motexafin lutetium and pharmacological study
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: May 2004to Jan 2006
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies

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

Read the 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.

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.

Conditions: Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer
Being tested: EF5, motexafin lutetium, pharmacological study
Medical subject headings: Appendiceal Neoplasms, Fallopian Tube Neoplasms, Gastrointestinal Stromal Tumors, Carcinoma, Hepatocellular, Sarcoma, Colonic Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EF5Drug
Given IV
motexafin lutetiumDrug
Also called Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex
Given IV
pharmacological studyOther
Also called pharmacological studies
Correlative studies

Study groups in NCT00087191
Study group	Role	What they receive
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. Receives: Drug: EF5; Drug: motexafin lutetium; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At the time of surgery
Pattern and presence of EF5 binding
EF5 biding will be quantified.
Measured: 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.
Measured: Up to 60 days following EF5 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2004Jan 2006

First posted12 Jul 2004 (estimated)
Study startMay 2004
Primary completionJan 2006

Why it stopped: Administratively complete.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Adult Primary Liver CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00087191
Sponsor's protocol ID: NCI-2012-02607
Other IDs: UPCC# 04204, P01CA087971, CDR0000373812
Status last verified: Jan 2013
First submitted: 8 Jul 2004
Last updated: 16 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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