A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer

NCT00369447 | Terminated Phase 1

• 1 other identifier: YMB1000-010
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 13

Brief Summary

This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment. The Phase I component of this study has been completed. The Phase II is now closed to recruitment.

Conditions

Non-small-cell Lung Cancer

Keywords

Non small cell lung cancer; NSCLC; Nimotuzumab; TheraCIM; h-R3; YM BioSciences; Radiation; Non small cell lung cancer, Stage IIb, III and IV

Outcome Measures

Primary Outcomes (1)

• Phase II: Overall survival

  Every 8 weeks until disease progression

Secondary Outcomes (9)

• Phase I: Biologically effective dose

  2.5 Years

• Phase II: Overall response rate

  Every 8 weeks until disease progression

• Local response rate

  Every 8 weeks until disease progression

• Overall clinical benefit

  Every 8 weeks until disease progression

• Local clinical benefit

  Every 8 weeks until disease progression

Study Arms (2)

1

EXPERIMENTAL

200 mg dose

Procedure: External radiotherapy; Biological: nimotuzumab

2

PLACEBO COMPARATOR

Procedure: External radiotherapy; Biological: nimotuzumab

Interventions

External radiotherapy PROCEDURE

Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable

1; 2

nimotuzumab BIOLOGICAL

weekly dose until disease progression

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients receiving any other investigational agents
• Previous treatment with anti-EGF-R drug(s)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study.
• Prior thoracic radiotherapy for this condition
• Prior chemotherapy within 4 weeks of enrolment
• Lesions not suitable for radiotherapy
• Patients with known sero positive HIV
• Patients with uncontrolled hypercalcemia
• Patients with progressive or untreated brain metastases or treated brain metastases but unable to discontinue steroids
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator
• Pregnant or breast-feeding women
• Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; patients with other prior malignancies are eligible providing prior malignancy cannot be clinically confused with the diagnosis of NSCLC in the opinion of the treating oncologist; in particular, there should be no evidence of current disease activity with respect to the prior malignancy
• Life expectancy of less than 8 weeks

Sponsors & Collaborators

• YM BioSciences: lead
• CIMYM BioSciences: collaborator

Study Sites (13)

Florida Cancer Institute - New Hope

New Port Richey, Florida, 34655, United States

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

London Regional Cancer Center

London, Ontario, N6A 4L6, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Thunderbay Regional hospital Center

Thunderbay, Ontario, P7B 6V4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T-2M4, Canada

Location

Centre Hospitalier de L'Universite de Montreal - Hôpital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Segal Cancer Center - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hotel Dieu Hospital

Québec, Quebec, G1R 2J6, Canada

Location

National Cancer Center Singapore

Singapore, 160610, Singapore

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gwyn Bebb, MD

  Tom Baker Cancer Center

  PRINCIPAL INVESTIGATOR

• Anthony Brade, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 1, 2011

Record last verified: 2011-06

Locations

SG (1); US (1); CA (11)