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NCT00924209 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Neo-Adjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2) Non-Squamous Cell Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT00924209: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00924209 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924209, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: * Surgical resection is the treatment of choice for patients with lung cancer, and cure after resection generally depends on whether lymph nodes are involved. A patient with Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the chest (mediastinum). * Studies have shown that surgery alone as a treatment for Stage IIIA (N2) lung cancer is not as effective as chemotherapy followed by surgery. * Giving chemotherapy upfront may prevent the spread of Stage IIIA (N2) lung cancer tumors, and may shrink the tumors to allow adequate surgery to be performed. It is also thought that chemotherapy is usually better tolerated before major surgery than after, so higher doses can be given. Objectives: * To determine the effectiveness of the combination of three anti-cancer drugs (gemcitabine, cisplatin, and bevacizumab) given before surgery. * To find out what effects this drug combination may have on the patient and the cancer. * To determine if the combination of all three drugs given prior to surgery is more effective and as safe, safer, or less safe than other drug combinations given before surgery. Eligibility: * Patients with Stage IIIA (N2) lung cancer who have not had chemotherapy, radiation, or surgery to treat the cancer. Design: * Evaluations before the treatment period to determine eligibility: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Tests to evaluate heart and lung function, such as an echocardiogram. * Blood and urine tests. * Disease evaluation with computed tomography (CT), chest X-ray, positron emission tomography (PET) scans, and bronchoscopy/mediastinoscopy (examinations of the inside of the chest and lungs). * Treatment with intravenous gemcitabine, cisplatin, and bevacizumab for three 21-day cycles. * Cycles 1 and 2 - Gemcitabine on day 1 and day 8, cisplatin on day 1, bevacizumab on day 1. * Cycle 3 - Gemcitabine on day 1 and
Interventions
- DRUG Bevacizumab
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Gemcitabine
- PROCEDURE Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00924209
The ClinicalTrials.gov registry entry for NCT00924209 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 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 Bevacizumab is the first listed.
NCT00924209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00924209 about?
NCT00924209 is a clinical study titled "A Phase II Study of Neo-Adjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2) Non-Squamous Cell Non-Small Cell Lung Cancer". Background: * Surgical resection is the treatment of choice for patients with lung cancer, and cure after resection generally depends on whether lymph nodes are involved. A patient with Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the chest (mediastinum). * Stud...
What is the current status of trial NCT00924209?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2009-03. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00924209?
The interventions under investigation include: Bevacizumab (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Gemcitabine (DRUG), Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00924209?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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