Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer

Esophageal Squamous Cell Cancer Clinical Trial

Official title:

Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01336049
• Other study ID #: N+TP-AEC3
• Status: Recruiting
• Phase: Phase 2
• First received: March 29, 2011
• Last updated: April 14, 2011
• Start date: March 2011

Study information

• Verified date: March 2011
• Source: Peking University
• Contact: xiaodong zhang, MD
• Phone: 86-01-88196175
• Email: zxd0829[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before,the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Having signed informed consent

• Age 18 to 75 years old

• Histologically confirmed esophageal squamous carcinoma, Unresectable recurrent or metastatic disease,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months,recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of paclitaxel as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy

• Sex is not limited

• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)

• Karnofsky performance status =80

• Life expectancy of = 3 month

• WBC > 4,000/mm3, absolute neutrophil count =2000/mm3, platelet > 100,000/mm3, Hb > 10g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (=5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.0 times ULN

• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38?;

• Normal ECG and heart function

• Fertile patients must use effective contraception

• Good compliance

Exclusion Criteria:

• Previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy

• Known hypersensitivity to Nimotuzumab,Paclitaxel,Cisplatin

• Only with Brain or bone metastasis

• Tumor with length = 10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung

• No measurable lesions, eg. pleural fluid and ascites

• Suffer from severe heart disease or disease with other important organs

• Chronic diarrhea or renal dysfunction

• Pregnancy or lactation period

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

• Chronic diarrhea

• Mentally abnormal or disable cognition,including CNS metastasis

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Cancer
• Neoplasms, Squamous Cell

Intervention

Drug:
• Nimotuzumab
Nimotuzumab 200mg/week

Locations

Country	Name	City	State
China	Xiaodong Zhang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation	6 weeks	No
Secondary	overall survival of all participants	OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost	2 years	No
Secondary	progression free survival	the follow-up visit of PFS will be performed every 2 cycles	1 year	No
Secondary	adverse events	any adverse event will be record on CRF for safety control	participants will be followed for the duration of hospital stay, an expected average of 1 week	Yes