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

Phase 2

• Conditions: Esophageal Squamous Cell Cancer
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT01336049
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-04-14
• Last Update Submitted: 2011-04-14
• Study First Posted: 2011-04-15
• Last Update Posted: 2011-04-15
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab	Nimotuzumab	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	6 weeks	CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Secondary Outcome Measures

Name	Time	Method
overall survival of all participants	2 years	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
progression free survival	1 year	the follow-up visit of PFS will be performed every 2 cycles
adverse events	participants will be followed for the duration of hospital stay, an expected average of 1 week	any adverse event will be record on CRF for safety control

Trial Locations

Locations (1)

Xiaodong Zhang; 🇨🇳 Beijing, Beijing, China