Overview

Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease are to be recruited in the study. In the current study, the efficacy and safety of Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate precision rather than controlling type I&II error. Assuming the target PFS is 6.7m, 60 patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will be enrolled.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
307 Hospital of PLA
Fudan University
Nanfang Hospital of Southern Medical University
Second Affiliated Hospital of Suzhou University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shandong Provincial Hospital
Shandong Tumor Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Tianjin Medical University General Hospital
Tongji Hospital
West China Hospital
Treatments:
Capecitabine
Docetaxel
Trastuzumab
Criteria
Inclusion Criteria:

1. Male or female. Age: 18-75 years.

2. 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.

3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1, assessed using imaging techniques (CT or MRI).

4. 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.

5. ECOG Performance status 0-1.

6. Life expectancy of at least 3 months.

7. Signed informed consent.

8. 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:

1. 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.

2. Baseline LVEF < 50% (measured by echocardiography or MUGA).

3. Patients with dyspnea at rest due to complications of advanced malignancy or other
disease, or who require supportive oxygen therapy.

4. 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).

5. Known dihydropyrimidine dehydrogenase (DPD) deficiency.

6. History or clinical evidence of brain metastases.

7. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly
controlled diabetes.

8. Positive serum pregnancy test in women of childbearing potential.

9. Subjects with reproductive potential not willing to use an effective method of
contraception.

10. Received any investigational drug treatment within 4 weeks of start of study
treatment.

11. 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).

12. Major surgery within 4 weeks of start of study treatment, without complete recovery.

13. Patients with known active infection with HIV, HBV, or HCV.

14. Known hypersensitivity to any of the study drugs.