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NCT00256815 · ClinicalTrials.gov registry record · Phase 1
Combination of Weekly Chest Radiotherapy and Oral Navelbine for the Palliation of Advanced Non Small Cell Lung Cancer: A Phase I Study
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Clinical Oncology Research Associates.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT00256815 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that has completed, run by Clinical Oncology Research Associates. The registered enrollment target is 35 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00256815, a Phase 1 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Clinical Oncology Research Associates.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most subjects cannot be cured from the disease, however, treatment can help subjects to live longer and better by keeping the cancer under control. All treatment offered to is primarily pursuing that goal. Subjects at this stage of their disease traditionally receive radiation therapy or chemotherapy, both treatments in succession or both concurrently. Recently, the administration of both methods of treatment concurrently has been employed and indicate somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids used in combination with radiation therapy appear promising as determined in small studies. The drug Navelbine is part of this class of drugs. This drug is approved as an infusion through the veins. The pill form is under development and will be used in this form in this treatment program. For this protocol, radiation will be administered using a schedule which is more convenient for patients, by once weekly chest irradiation for a total of 12 weeks. Use of this schedule was determined to be as good as the more commonly used daily radiotherapy. The once weekly schedule is less cumbersome as it involves less visits. The rationale and reason why you are being asked to participate in this program is to study whether the drug Navelbine can be given together with the once weekly radiation schedule. Radiation will be administered in two fractions, 6 hours apart on one day. For this program, the drug Navelbine would be made available as a pill, and would not have to be infused through the vein. The proposed protocol will use increasing doses of the drug Navelbine in pill form to find the highest dose of Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject will receive one dose of Navelbine, which is higher than the dose o
Conditions Studied
Interventions
- DRUG chemotherapy
- PROCEDURE Radiation
Study Locations (1)
Louisiana
- LSUHSC - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2003-03 |
| Est. Completion | 2005-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00256815
The ClinicalTrials.gov registry entry for NCT00256815 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower). The listed sponsor is Clinical Oncology Research Associates, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which chemotherapy is the first listed.
NCT00256815 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT00256815 about?
NCT00256815 is a clinical study titled "Combination of Weekly Chest Radiotherapy and Oral Navelbine for the Palliation of Advanced Non Small Cell Lung Cancer: A Phase I Study". The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most subjects cannot be cured from the disease, however, treatment can help subjects to live longer and better by keeping th...
What is the current status of trial NCT00256815?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2003-03. Estimated completion is 2005-09.
What conditions does trial NCT00256815 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT00256815?
The interventions under investigation include: chemotherapy (DRUG), Radiation (PROCEDURE).
Who is sponsoring clinical trial NCT00256815?
This trial is sponsored by Clinical Oncology Research Associates, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00256815 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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