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NCT00923273 · ClinicalTrials.gov registry record · Phase 1
Sirolimus and Pemetrexed to Treat Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00923273: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923273 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923273, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Background: The drug pemetrexed is used to treat non-small cell lung cancer (NSCLC) that does not respond to standard therapy or that has recurred after standard therapy; however, only 9 in 100 patients respond to pemetrexed. Sirolimus is a drug that blocks a protein in cells called mammalian target of rapamycin (mTOR). In cancer cells, mTOR is active when it should not be, allowing the cells to grow uncontrollably. This protein is unusually active in many cases of NSCLC. By blocking the activity of mTOR, sirolimus may make the cancer cells more responsive to treatment with pemetrexed. Objectives: To determine if sirolimus in combination with pemetrexed is safe and well tolerated in patients with NSCLC. To determine the highest safe dose of pemetrexed combined with sirolimus. To look at the ability of sirolimus and pemetrexed to fight NSCLC. To learn how the body eliminates sirolimus and pemetrexed. Eligibility: Patients 18 years of age and older with NSCLC whose disease does not respond to standard therapy or has recurred after treatment with standard therapy. Design: Biopsy before treatment starts, if the tumor is easy to reach by bronchoscopy or can be done by needle biopsy. This procedure is optional. Drug treatment, as follows: * Day 1: Intravenous (through a vein) infusions of pemetrexed. Small groups (3 to 6) of patients are given pemetrexed at a certain dose level. If the first group experiences no significant side effects, the next group receives a higher dose. This continues in succeeding groups for up to five dose levels until the maximum tolerated study dose (highest dose that patients can be given safely) is determined. * To lessen the side effects of pemetrexed, patients also receive a Vitamin B12 injection every 21 days, folic acid tablets daily, and dexamethasone tablets twice a day the day before, the day of, and the day after pemetrexed infusions. * Days 1-21: Sirolimus tablets by mouth. Evaluations during the treatment period: * His
Interventions
- DRUG Sirolimus
- DRUG Pemetrexed
- DIETARY_SUPPLEMENT Vitamin B12
- DRUG FDG-PET
- DIETARY_SUPPLEMENT Folic acid tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2008-02-29 |
| Est. Completion | 2013-03-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923273
The ClinicalTrials.gov registry entry for NCT00923273 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.
NCT00923273 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923273 about?
NCT00923273 is a clinical study titled "Sirolimus and Pemetrexed to Treat Non-Small Cell Lung Cancer". Background: The drug pemetrexed is used to treat non-small cell lung cancer (NSCLC) that does not respond to standard therapy or that has recurred after standard therapy; however, only 9 in 100 patients respond to pemetrexed. Sirolimus is a drug that blocks a protein in cells called mammalian targ...
What is the current status of trial NCT00923273?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2008-02-29. Estimated completion is 2013-03-10.
What interventions are being tested in trial NCT00923273?
The interventions under investigation include: Sirolimus (DRUG), Pemetrexed (DRUG), Vitamin B12 (DIETARY_SUPPLEMENT), FDG-PET (DRUG), Folic acid tablets (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00923273?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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