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NCT00001944 · ClinicalTrials.gov registry record · Phase 1
Vinorelbine and XR9576 to Treat Cancer
A Phase 1 study of Breast Cancer and Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00001944: Completed Phase 1 study of Breast Cancer and Cancer, sponsored by National Cancer Institute (NCI).
NCT00001944 is a Phase 1 study of Breast Cancer and Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001944, a Phase 1 study of Breast Cancer and Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Tumor resistance to anti-cancer drugs is a major problem in cancer treatment. Studies have found that a protein (P-glycoprotein) on some cancer cells pumps chemotherapy drugs out of the cells, reducing treatment effectiveness. In laboratory tests, an experimental drug called XR9576, has blocked pumping by this protein. It is being used in this study to try to increase the amount of the anti-cancer drug vinorelbine, in cancer cells. Vinorelbine has been shown in several clinical trials to be effective against some advanced cancers, including breast, lung and ovarian, and is one of the drugs pumped out of tumor cells by P-glycoprotein. Patients with cancer 18 years and older may be eligible for this study. Candidates will be screened with tests that may include blood and urine tests, electrocardiogram, echocardiogram, CT scans, X-rays, and nuclear medicine studies. A tumor biopsy may be done for diagnostic or research purposes. Study participants will undergo tumor imaging with the radioactive drug Tc-99m Sestamibi. This drug accumulates in tumor cells and is eliminated from them in much the same way that some cancer drugs are eliminated from cells. The drug is injected into a vein and a series of pictures are taken with a gamma camera. After this baseline scan, patients will receive a dose of XR9576 and undergo a second scan 24 hours later. The scan will show whether XR9576 affects the accumulation and elimination of Sestamibi in tumor cells. This procedure may provide a way to monitor cancers for evidence of chemotherapy resistance and show if XR9576 can improve the effectiveness of therapy. At least 10 days after the baseline and XR9576 scans, patients will begin the first of 3 or more 21-day cycles of vinorelbine treatment. On days 1 and 8 of each cycle, patients will receive a 30-minute infusion of XR9576 intravenously (through a vein) followed by vinorelbine, infused over a 6- to 10-minute period. (In some patients, XR9576 will be administered before only one
Conditions Studied
Interventions
- DRUG Vinorelbine
- DRUG XR9576
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1999-12 |
| Est. Completion | 2001-06 |
| Phase | Phase 1 |
What the finished NCT00001944 record still lists
NCT00001944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Vinorelbine is the first listed.
NCT00001944 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001944 about?
NCT00001944 is a clinical study titled "Vinorelbine and XR9576 to Treat Cancer". Tumor resistance to anti-cancer drugs is a major problem in cancer treatment. Studies have found that a protein (P-glycoprotein) on some cancer cells pumps chemotherapy drugs out of the cells, reducing treatment effectiveness. In laboratory tests, an experimental drug called XR9576, has blocked pump...
What is the current status of trial NCT00001944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1999-12. Estimated completion is 2001-06.
What conditions does trial NCT00001944 study?
This clinical trial studies the following conditions: Breast Cancer, Cancer, Lung Cancer, Ovarian Cancer.
What interventions are being tested in trial NCT00001944?
The interventions under investigation include: Vinorelbine (DRUG), XR9576 (DRUG).
Who is sponsoring clinical trial NCT00001944?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001944 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001944's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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