Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02229045|
Recruitment Status : Unknown
Verified August 2014 by Ruihua Xu, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastric Caner||Drug: Albumin Bound Paclitaxel Drug: 5-FU||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Albumin Bound Paclitaxel With 5-FU/CF
Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Drug: Albumin Bound Paclitaxel
Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
Other Name: Abraxane
5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
- PFS(Progression-free survival ) [ Time Frame: 80% PFS events,, an expected average of 10 months ]The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death
- OS (Overall survival ) [ Time Frame: OS follow-up period: 18 months or 80% OS events, whichever occurs first ]Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
- ORR (Overall tumor response) [ Time Frame: 80% PFS events, an expected average of 10 months ]Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229045
|Contact: Ruihua Xu, PhD,MDfirstname.lastname@example.org|
|Contact: Dongsheng Zhang, PhD,MDemail@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ruihua Xu, Ph D,MD 862087343228|
|Contact: Dongsheng Zhang, Ph D,MD 862087343795 firstname.lastname@example.org|
|Principal Investigator:||Ruihua Xu, PhD,MD||Sun Yat-sen University|