Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-Small-Cell Lung Cancer Before Surgery

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, December 2008

First Received: November 21, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong Eli Lilly and Company
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563160

Purpose

To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis

Condition	Intervention	Phase
Lung Neoplasms	Drug: gemcitabine, carboplatin Procedure: surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-Small Cell Lung Cancer Before Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

pathological response rate [ Time Frame: 12 months ]

Secondary Outcome Measures:

progression-free survival [ Time Frame: 18 months ]
overall survival [ Time Frame: 18 months ]
quality of life measurements [ Time Frame: 18 months ]

Estimated Enrollment:	50
Study Start Date:	May 2005
Estimated Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer
Measurable or evaluable tumour on chest X-ray or CT scan.
No multiple ipsilateral or contralateral parenchymal tumours
Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563160

Contacts

Contact: Patricia Poon, Dr

(852) 2958 2310

pcm0806@netvigator.com

Locations

China
Queen Elizabeth Hospital	Recruiting
Hong Kong, China
Sub-Investigator: Che Mun Poon, Dr
Sub-Investigator: Chun Key Law, Dr
Sub-Investigator: Roger Ngan, Dr
Sub-Investigator: Chung Kong Kwan, Dr
Sub-Investigator: Cheuk Kin Lo, Dr
Sub-Investigator: Johnny Chan, Dr
Sub-Investigator: TK Au Yong, Dr
Sub-Investigator: Ting Lok Kwan, Dr
Sub-Investigator: Stella Cheung, Dr
Sub-Investigator: Timothy Yip

Sponsors and Collaborators

Hospital Authority, Hong Kong

Eli Lilly and Company

Investigators

Principal Investigator:

Siu Kie Au, Dr

Department of Clinical Oncology, Queen Elizabeth Hospital

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	(193-h)in QE/EC/I, HARECCTR0500015, 000904, B9E-IH-O333
Study First Received:	November 21, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00563160 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Carcinoma

Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009