Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2005 | ||||
| Last Updated Date | November 14, 2005 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) | ||||
| Official Title ICMJE | Phase II Trial of Bevacizumab (Avastin) Plus Pemetrexed (Alimta) and Carboplatin in Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) | ||||
| Brief Summary | Avastin is a novel antiangiogenic agent that has recently been shown to improve response rates and survival of patients with advanced nonsquamous non-small cell lung cancer when added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely incorporated into the treatment of these patients. Alimta is a recently approved chemotherapeutic that has shown activity against non-small cell lung cancer when given alone and in combination with carboplatin, has a favorable toxicity profile andrequires only a brief (10 minute) infusion time. Therefore we propose to study the combination of Avasin, Alimta, and Carboplatin administered as front-line therapy to patients with advanced nonsquamous non-small cell lung cancer. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Untreated Advanced Non-Small Cell Lung Cancer | ||||
| Intervention ICMJE | Drug: Avastin, Alimta | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: I am 18 years of age or older. I have advanced non-small lung cancer. I have not had any major surgical procedures within 28 days prior to my starting treatment. I have high blood pressure that is controlled. I am not on heparin, coumadin or lovonox for treatment of medical conditions. I do not have serious wound healing problems. I have not received any previous treatment, except radiation therapy for my disease. Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00254319 | ||||
| Other Study ID Numbers ICMJE | AVF3158'S | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | The Cooper Health System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Cooper Health System | ||||
| Verification Date | November 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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