Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Advanced Gastric Cancer Clinical Trial

Official title:

A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01015339
• Other study ID #: PAC-C
• Secondary ID: ML22697
• Status: Recruiting
• Phase: Phase 3
• First received: November 17, 2009
• Last updated: May 17, 2015
• Start date: November 2009
• Est. completion date: August 2015

Study information

• Verified date: May 2015
• Source: Peking University
• Contact: Zhihao Lu, MD
• Phone: 86-10-88196561
• Email: pppeirain[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether Paclitaxel 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: 320
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having signed informed consent

• Age= 18 years old

• Histologically confirmed gastric adenocarcinoma

• Unresectable recurrent or metastatic disease

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

• Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.

• Measurable disease according to the RECIST criteria

• Karnofsky performance status =60

• Life expectancy of =2 month

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

• ALT and AST<2.5 times ULN (=5 times ULN in patients with liver metastases)

• Serum albumin level =3.0g/dL

• Serum AKP < 2.5 times ULN

• Serum creatinine <ULN, and CCr < 60ml/min

• Bilirubin level < 1.5 ULN

• WBC>3,000/mm3, absolute neutrophil count =2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

• Brain metastasis (known or suspected)

• Previous systemic therapy for metastatic gastric cancer

• Inability to take oral medication

• Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy

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

• Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.

• Allergic constitution or allergic history to protium biologic product or any investigating agents.

• 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.

• Pregnancy or lactation period

• Any investigational agent within the past 28 days

• Other previous malignancy within 5 year, except non-melanoma skin cancer

• Previous adjuvant therapy with capecitabine+platinum,

• Pre-existing neuropathy>grade 1

• 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
• Advanced Gastric Cancer

Intervention

Drug:
• Paclitaxel
80mg/m2 infusion,d1,d8 every 3 weeks
• capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
• capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
• cisplatin
80mg/m2, day 1 of every 3 weeks

Locations

Country	Name	City	State
China	Department of GI Oncology, Peking University, School of Oncology	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Roche Pharma AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		3 year	No
Secondary	Tumor response rate		1 year	No
Secondary	Disease control rate		1 year	No
Secondary	Overall survival		5 year	No
Secondary	adverse evens		5 year	Yes