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
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Condition or disease | Intervention/treatment | Phase |
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Stomach Neoplasms Neoplasms Metastasis ERBB2 Gene Amplification | Drug: Trastuzumab Drug: Docetaxel Drug: Capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: Trastuzumab
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 Drug: Docetaxel Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.
Other Name: Taxotere Drug: Capecitabine 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female. Age: 18-75 years.
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).
- HER2 positive tumor (primary tumor or metastasis, HER2 positive as defined by IHC2+ and a confirmatory FISH+ result (HER2:CEP17 ratio ≥2), or by an IHC 3+ result) as assessed by the central laboratory. Accurate and validated assay methods will be used.
- ECOG Performance status 0-1.
- Life expectancy of at least 3 months.
- Signed informed consent.
- Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrollment into the study; adjuvant/neoadjuvant therapy with docetaxel is not allowed).
9 .Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe).
10. Patients with active (significant or uncontrolled) gastrointestinal bleeding.
11. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurologic toxicity ≥ grade 2 NCI-CTCAE version 4.0.
12. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
13. Hematologic, Biochemical and Organ Function 14. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L. 15. Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or albumin < 25 g/L.
16. Creatinine clearance < 60 mL/min.
Exclusion Criteria:
- History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- Baseline LVEF < 50% (measured by echocardiography or MUGA).
- Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- History or clinical evidence of brain metastases.
- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- Positive serum pregnancy test in women of childbearing potential.
- Subjects with reproductive potential not willing to use an effective method of contraception.
- Received any investigational drug treatment within 4 weeks of start of study treatment.
- Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity).
- Major surgery within 4 weeks of start of study treatment, without complete recovery.
- Patients with known active infection with HIV, HBV, or HCV.
- Known hypersensitivity to any of the study drugs.

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
China, Guangdong | |
Medical Oncology,Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Ruihua Xu, M.D,Ph.D | Sun Yat-sen University |
Responsible Party: | Ruihua Xu, Vice-president and Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02004769 |
Other Study ID Numbers: |
ML28670 |
First Posted: | December 9, 2013 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Metastatic gastric or gastro-esophageal junction cancer Trastuzumab HER2-positive |
Capecitabine Docetaxel First-line therapy |
Neoplasms Neoplasm Metastasis Stomach Neoplasms Neoplastic Processes Pathologic Processes Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Docetaxel Capecitabine Trastuzumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents, Immunological |