Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02004769|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Neoplasms Metastasis ERBB2 Gene Amplification||Drug: Trastuzumab Drug: Docetaxel Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Trastuzumab in Combination With Chemotherapy (Docetaxel Plus Capecitabine) For First Line Treatment of Her2-Positive Advanced Gastric or Gastro-Esophageal Junction Cancer|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Trastuzumab, Capecitabine, Docetaxel
Trastuzumab(8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) Capecitabine(2000mg/m2d, d1-14,every 3 weeks) Docetaxel (60mg/m2 every 3 weeks for 6 cycles).All patients will continue to receive trastuzumab and Capecitabine until either disease progression, occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.
Other Name: Herceptin
Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.
Other Name: Taxotere
Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.
Other Name: Xeloda
- PFS(Progression-free survival ) [ Time Frame: up to 4 years ]The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death,
- ORR (Overall tumor response) [ Time Frame: up to 4 years ]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.
- OS (Overall survival ) [ Time Frame: up to 4 years ]Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
- Safety [ Time Frame: up to 4 years ]Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
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): NCT02004769
|Medical Oncology,Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Ruihua Xu, M.D,Ph.D||Sun Yat-sen University|