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

Primary Purpose

Esophageal Squamous Cell Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xiaodong ZhangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate

CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Secondary Outcome Measures

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

progression free survival

the follow-up visit of PFS will be performed every 2 cycles

adverse events

any adverse event will be record on CRF for safety control

Full Information

NCT ID

NCT01336049

First Posted

March 29, 2011

Last Updated

April 14, 2011

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01336049

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Intervention Description

Nimotuzumab 200mg/week

Primary Outcome Measure Information:

Title

Objective response rate

Description

CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

overall survival of all participants

Description

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

Time Frame

2 years

Title

progression free survival

Description

the follow-up visit of PFS will be performed every 2 cycles

Time Frame

1 year

Title

adverse events

Description

any adverse event will be record on CRF for safety control

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xiaodong zhang, MD

Phone

86-01-88196175

zxd0829@yahoo.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

jifang gong, MD

Phone

86-01-88196088

gongjifang@gmail.com

Facility Information:

Facility Name

Xiaodong Zhang

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

xiaodong zhang, MD

Phone

86-10-88196175

zxd0829@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

xiaodong zhang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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