An interventional study of EF5 and motexafin lutetium in Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix and Fallopian Tube Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.
Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Diagnostic
Among 66 studies in Appendiceal Neoplasms with a site in United States — 19 open to participants now, 24 under way, 1 of them phase 3. Appendiceal Neoplasms · United States.
Among the 66 studies in Appendiceal Neoplasms with a site in United States, this one is the 29th largest by enrollment of the 52 interventional ones that give a count, is one of 2 that started in 2004, is one of 13 with no phase, and was the 14th registered.
86 studies on the registry are indexed under Appendiceal Neoplasms; 25 are open to participants now.
Browse Appendiceal Neoplasms studies →19 of the 66 studies in Appendiceal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
The Methodist Hospital Research Institute · Sites in United States
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
City of Hope Medical Center · Sites in United States
Yale University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 24 Appendiceal Neoplasms studies recruiting now, 17 (71%) set no upper age limit and 4 (17%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
66 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 16 · Phase 3 3 · Phase 4 1
First in 1997; this study’s year is marked. 2 started in 2004.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 44 across 63 interventional studies indexed under Appendiceal Neoplasms.
Median enrollment 42 across the 52 interventional studies, 120 across the 10 observational. Of the 40 that completed or were terminated, 12 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 66 have an industry lead sponsor. The 10 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
National Cancer Institute (NCI) has 9 studies filed under Appendiceal Neoplasms — fewer than ten, so there is no comparison to draw.
8 of the studies in Appendiceal Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07587268City of Hope Medical CenterMolecular Profiling for Risk Stratification in Appendiceal Cancer | 2027-01-01 |
| NCT04907643Cedars-Sinai Medical CenterVirtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes | 2027-01-01 |
| NCT05462717Revolution Medicines, Inc.Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | 2027-03-31 |
| NCT07124351Cedars-Sinai Medical CenterIntraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™) | 2027-08-31 |
| NCT01815359Memorial Sloan Kettering Cancer CenterICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis | 2027-09 |
Among the 66 studies in Appendiceal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
Inclusion Criteria:
confirmed or suspected diagnosis of 1 of the following:
Intra-abdominal of 1 of the following types:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: motexafin lutetium · Other: pharmacological study
Given IV
Given IV
Also known as: Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex, PCI-0123
Correlative studies
Also known as: pharmacological studies
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.
Time frame: 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.
Time frame: At the time of surgery
Pattern and presence of EF5 binding
EF5 biding will be quantified.
Time frame: 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.
Time frame: Up to 60 days following EF5 infusion
The record gives a start of May 2004 and a primary completion of Jan 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: EF-5 · Motexafin lutetium
National Cancer Institute (NCI) →