Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

Gastric Cancer Clinical Trial

Official title:

A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01468389
• Other study ID #: AGC001-307PLAH-XJM
• Status: Recruiting
• Phase: Phase 3
• First received: November 4, 2011
• Last updated: November 8, 2011
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2011
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Xu jianming, M.D.
• Phone: 861051128358
• Email: jmxu2003[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Having signed informed consent

2. Age= 18 years old

3. Histologically confirmed gastric adenocarcinoma

4. Unresectable recurrent or metastatic disease

5. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months

6. Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.

7. Measurable disease according to the RECIST criteria

8. ECOG performance status =2

9. Life expectancy of =3 month

10. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks

11. ALT and AST=2.5 times ULN (=5 times ULN in patients with liver metastases) Serum albumin level =3.0g/dL Serum creatinine =1.5ULN Bilirubin level = 1.5 ULN WBC>3,000/mm3, absolute neutrophil count =1500/mm3, platelet>90,000/mm3, Hb>8g/dl

Exclusion Criteria:

1. Brain metastasis (known or suspected)

2. Previous systemic therapy for metastatic gastric cancer

3. Inability to take oral medication

4. Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy

5. Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry

6. Allergic constitution or allergic history to any investigating agents.

7. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.

8. Pregnancy or lactation period

9. Any investigational agent within the past 28 days

10. Other previous malignancy within 5 year

11. Pre-existing neuropathy>grade 1

12. Legal incapacity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine
900-1000mg/m2 bid, days 1-14, every 3 weeks
• capecitabine
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		1 year	Yes
Secondary	Tumor response rate		1 year	Yes
Secondary	disease control rate		1 year	Yes
Secondary	overall survival		3 year	Yes
Secondary	adverse events		3 year	Yes