EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell … (NCT00087191) | Clinical Trial Compass
TerminatedNot Applicable
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Stopped: Administratively complete.
United States30 participantsStarted 2004-05
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motexafin lutetium uptake in tumors and normal tissues
Timeframe: At the time of surgery
2
Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue
Timeframe: At the time of surgery
3
Pattern and presence of EF5 binding
Timeframe: At the time of surgery
4
Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0