Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma

Stomach Neoplasms Clinical Trial

Official title:

Cisplatin and S-1 With or Without Nimotuzumab for Patients With Previously Untreated Advanced Gastric Adenocarcinoma: a Single-center, Randomised, Open-label, Parallel-group, Controlled Phase 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370849
• Other study ID #: 20150207
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2015
• Last updated: February 19, 2015
• Start date: October 2009
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Cancer Hospital, Chinese Academy of Medical Sciences
• Study type: Interventional

Clinical Trial Summary

In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group.

The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2015
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. provision of written informed consent;

2. male or female; and aged = 18 years;

3. Histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction;

4. At least one radiographically documented measurable lesion according to Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria;

5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life expectancy = 3months;

6. No previous palliative chemotherapy;

7. Adequate function of vital organs: white blood cells (WBC) = 4.0×109/L, neutrophils (ANA) = 1.5 × 109/L, platelets = 100 × 109/L, hemoglobin = 90g/L (blood transfusion is permitted if necessary), serum bilirubin = 1 times the upper normal limit (UNL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the UNL, alkaline phosphatase (AKP) = 5 times the UNL, creatinine (Cr) = 1 times the UNL, normal electrocardiography (ECG).

Exclusion Criteria:

1. pregnant or lactating patients, or reproductive women without effective contraception;

2. Patients with only non-measurable disease: small lesions (longest diameter < 10mm or pathological lymph nodes with = 10 to < 15mm short axis), Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung; abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques.

3. Symptomatic of brain metastasis;

4. Patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (HBV carrier can be enrolled if circumstance permits );

5. No previous radiotherapy for measurable lesions.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• nimotuzumab
nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks
• cisplatin
cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks
• S-1
S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ;

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)		5 years	No
Secondary	Time to progression as measured by RECIST 1.1		5 years	No
Secondary	Progression-free survival measured by RECIST 1.1		5 years	No
Secondary	Treatment safety and toxicity as measured by Common Toxicity Criteria for Adverse Effects(CTCAE 3.0)		5 years	Yes