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Trial: NCT00998166 [RDF]

Label NCT00998166
Slug nct00998166
Trialid NCT00998166
Lookup name NCT00998166
Lastchanged date September 10, 2013
Firstreceived results date
Firstreceived date October 14, 2009
Id info nct id NCT00998166
Overall status Terminated
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 4
Number of arms 1
Is section 801 Yes
Is fda regulated Yes
Brief title A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Carcinoma (NSCLC)
Official title A Phase 2 Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy in Patients With Advanced Non-Squamous, Non-Small Cell Lung Carcinoma
Study type Interventional
Id info nct alias
Completion date October 2012
Verification date September 2013
Why stopped Poor enrollment
Id info org study id AAAB9652
Required header url
Study design Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Columbia University
Primary completion date October 2012
Brief summary
Number of groups
Required header download date processed this data on September 07, 2016
Phase Phase 2
Start date June 2007
Has expanded access No
Biospec descr
Detailed description The majority of patients with NSCLC present with inoperable locally advanced or metastatic disease for which no curative therapy is available. For these patients, platinum based doublet combination regimens have become standard of care due to increased survival rates over platinum therapy alone. In order to try to improve on the overall survival, clinicians have attempted to add a third cytotoxic agent to their standard regimen(s). Although this approach demonstrated an improved objective response, no additional benefit was noted in overall survival. Recent development and approval of new targeted chemotherapies during the past 10 years has prompted clinical trials to test the efficacy of newly FDA approved agents such as gefitinib, erlotinib, and bevacizumab in advanced NSCLC. Although gefitinib and erlotinib have both demonstrated clinical activity in refractory NSCLC, neither agent improved clinical outcome when added to standard 1st line platinum based chemotherapy. In contrast, a recently completed randomized Phase 3 trial investigating the addition of bevacizumab to 1st line paclitaxel plus carboplatin chemotherapy reported a 23% improvement in the median overall survival for the paclitaxel/carboplatin plus bevacizumab treatment arm (12.5m vs. 10.2m; p=0.007). It is therefore appealing to study a cisplatin combination with bevacizumab to determine if there is any additive benefit. Pemetrexed is an ideal agent to use in combination with cisplatin since it is well tolerated and efficacy is comparable to other cisplatin combinations. Patients will receive a maximum of 6 cycles. Those who complete 1 cycle will be evaluated for toxicity; more than 1 cycle, response.
Condition browse 28e3ae238e01697f1749f42c3e15bf67
Intervention browse 456838bc28f1dbad25c63e447e3cd65e
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group f27a73662cb01de6720c9f11fe650836
Oversight info United States: Institutional Review Board (Oversight_info)
Eligibility ac6d975567ff9a7b7dff9f57d4217fec
Keywords NSCLC
Conditions Non-small Cell Lung Cancer
Locations 8c42bd71cc4c01cc3f997695528cc378, 969089685db20f25d6eec49c81a0dac1
Links None
Results references None
Arm groups Pemetrexed, Cisplatin, Bevacizumab (Arm Group)
Location countries United States
Interventions Pemetrexed, Cisplatin, Bevacizumab (Intervention)
Secondary outcomes 5f1137f89f6eab6a45f6806f72cbed03
References None
Primary outcomes 5b6006130fc2d2108aa96fbd9dbc6892
Removed countries None
Overall officials 2fb46caa52900461d4474db1529f1df4