Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

Sponsor

Biotech Pharmaceutical Co., Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT05278728

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

15.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Nimotuzumab Drug: Irinotecan	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nimotuzumab and Irinotecan Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles	Drug: Nimotuzumab 200,400,600 or 800mg weekly until progression or AEs Drug: Irinotecan 180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Arm

Intervention/Treatment

Experimental: Nimotuzumab and Irinotecan

Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Drug: Nimotuzumab

200,400,600 or 800mg weekly until progression or AEs

Drug: Irinotecan

180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Outcome Measures

Primary Outcome Measures

The rate of grade 3/4 toxicity [3 months]

Secondary Outcome Measures

The maximum tolerated [3 months]
The complete response rate [3 months]
The partial rate [3 months]
The disease control rate [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China People's Liberation Army (PLA)81 Hospital	Nanjing	Jiangsu	China
2	Peking University, School of Oncology, Beijing Cancer Hospital & Institute	Beijing		China	100036