NCT00972465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 7, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

September 4, 2009

Last Update Submit

September 4, 2009

Conditions

Advanced Colorectal Cancer

Keywords

nimotuzumab colorectal cancer chemotherapy

Outcome Measures

Primary Outcomes (1)

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

    within study period

Secondary Outcomes (1)

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

    3 months

Interventions

Nimotuzumab and chemotherapyDRUG

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)

Also known as: Nimotuzumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

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

Beijing, China

RECRUITING

China People's Liberation Army (PLA)81 Hospital

Nanjing, China

NOT YET RECRUITING

MeSH Terms

Interventions

nimotuzumabDrug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shen Lin

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Lin

CONTACT

86-01-88196561

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 7, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

September 7, 2009

Record last verified: 2009-09

Locations

CN(3)