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To Evaluate the Efficacy and Safety of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients:a Phase II Single Center Prospective Clinical Trial


Phase 2
18 Years
75 Years
Not Enrolling
Both
Gastric Adenocarcinoma

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Trial Information

To Evaluate the Efficacy and Safety of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients:a Phase II Single Center Prospective Clinical Trial


A single arm,open,phase II study of Nab-Paclitaxel plus Capecitabine as the first-line
treatment in advanced gastric cancer.

Nab-Paclitaxel should be given intravenously on days 1 and 8 at a dose as follows. Treatment
should be repeated every 3 weeks:Nab-Paclitaxel:125 mg/m2; Capecitabine should be given
orally twice a day as follows for 14 consecutive days, followed by a 1-week rest. Treatment
should be repeated every 3 weeks. Capecitabine:1000mg/m2,twice daily (bid).

If applicable,the value of response and prognosis predictive factors are expected to be
identified.


Inclusion Criteria:



- signed informed consent form;

- histologically or cytologically confirmed gastric cancer;

- Age 18-75 years;

- Advanced or recurrent, metastatic disease;

- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;

- Life expectancy of at least 12 weeks;

- At least have one measurable disease(according to RECIST, Response Evaluation
Criteria in Solid Tumors );

- no prior history of chemotherapy or beyond 6 months after the end of systemic
adjuvant treatment;

- Haematopoietic status:

- Absolute neutrophil count > 1.5 x 109/L;

- Platelet count > 90 x 109/L;

- Hemoglobin at least 90g/l;

- Hepatic status:

- Bilirubin ≤ 1.5 x upper limit of normal (ULN);

- AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤ 5 times ULN (with liver
metastasis);

- ALP ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver or bone
metastasis);

- serum albumin ≥ 30g/L;

- Renal status:

- Creatinine ≤ 1.5 times ULN or calculated creatinine clearance, using the
Cockcroft-Gault formula, ≥ 40 mL/min;

- Able to swallow and retain oral medication;

Exclusion Criteria:

- peripheral neuropathy of grade 2 or greater;

- symptomatic brain metastasis;

- known history of uncontrolled or symptomatic angina;

- clinically significant arrhythmias, congestive heart failure, uncontrolled
hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic
therapy with oxygen;

- dementia, altered mental status, or any psychiatric condition that would prevent the
understanding or rendering of ICF;

- active or uncontrolled infection;

- pregnant or lactating women;

- dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine

- unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract
hemorrhage

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Description:

the follow-up visit of PFS will be performed every 6 weeks

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Yanqiao Zhang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Harbin Medical University

Authority:

China: Ethics Committee

Study ID:

YL2012-03

NCT ID:

NCT01641783

Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Gastric Adenocarcinoma
  • advanced
  • paclitaxel
  • capecitabine
  • first line therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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