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Study of Nimotuzumab to Treat Colorectal Cancer

Primary Purpose

Advanced Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab and chemotherapy

About this trial

This is an interventional treatment trial for Advanced Colorectal Cancer focused on measuring nimotuzumab colorectal cancer chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

Informed consent form signed before performing any of the study's specific procedures.
ECOG performance status 0-2.
Age > 18，both genders.
Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
Life expectancy more than 3 months.
K-ras is wild type
Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN
No brain metastasis

Exclusion Criteria:

Previous radiotherapy at lesions within three months
Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
Received other anti EGFR monoclonal antibody treatment
Complete or incomplete intestinal obstruction
Participation in other interventional clinical trials within 1 month
Psychiatric disease affected cognitive ability, including brain metastasis
Peripheral neuropathy lesion is more than I stage
History of serious allergic or allergy
Pregnant or breast-feeding women
Patients with the history of Serious lung or hear disease
Other malignant tumor

Sites / Locations

Sun Yat-Sen University Cancer Center
Peking University, School of Oncology, Beijing Cancer Hospital & InstituteRecruiting
China People's Liberation Army (PLA)81 Hospital

Outcomes

Primary Outcome Measures

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

Secondary Outcome Measures

To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment

Full Information

NCT ID

NCT00972465

First Posted

September 4, 2009

Last Updated

September 4, 2009

Sponsor

Peking University

Collaborators

Biotech Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00972465

Brief Title

Study of Nimotuzumab to Treat Colorectal Cancer

Official Title

Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Peking University

Collaborators

Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Detailed Description

Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment.Irinotecan will be administered once every 14 days,the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.

6. Conditions and Keywords

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

Advanced Colorectal Cancer

Keywords

nimotuzumab colorectal cancer chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab and chemotherapy

Other Intervention Name(s)

Nimotuzumab

Intervention Description

Experimental: Nimotuzumab and Irinotecan the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression) the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)

Primary Outcome Measure Information:

Title

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

Time Frame

within study period

Secondary Outcome Measure Information:

Title

To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent form signed before performing any of the study's specific procedures. ECOG performance status 0-2. Age > 18，both genders. Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI) Life expectancy more than 3 months. K-ras is wild type Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy. Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN No brain metastasis Exclusion Criteria: Previous radiotherapy at lesions within three months Other first line chemo-agents treatment except oxaliplatin ± fluorouracil Received other anti EGFR monoclonal antibody treatment Complete or incomplete intestinal obstruction Participation in other interventional clinical trials within 1 month Psychiatric disease affected cognitive ability, including brain metastasis Peripheral neuropathy lesion is more than I stage History of serious allergic or allergy Pregnant or breast-feeding women Patients with the history of Serious lung or hear disease Other malignant tumor

Central Contact Person:

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

Shen Lin

Phone

86-01-88196561

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shen Lin

Organizational Affiliation

Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ruihua Xu, M.D., Ph.D.

Phone

13922206676

xurh@mail.sysu.edu.cn

Facility Name

Peking University, School of Oncology, Beijing Cancer Hospital & Institute

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhou, MD. PhD

Phone

88196088

joelbmu@126.com

Facility Name

China People's Liberation Army (PLA)81 Hospital

City

Nanjing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shukui Qin

Phone

13905158713

qinshukui@csco.org.cn

12. IPD Sharing Statement

Learn more about this trial

Study of Nimotuzumab to Treat Colorectal Cancer

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