Phase I Imaging Study Evaluating Gem/Cis for Patients With Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00599755

Purpose

This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine and cisplatin in NSCLC.

Condition	Intervention	Phase
Carcinoma, Non-Small Cell Lung Cancer	Drug: Gemcitabine Drug: cisplatin	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine/Cisplatin

Further study details as provided by Merck:

Primary Outcome Measures:

Validate imaging platform and biomarkers. [ Time Frame: FDG response at Week 3 and 6 following chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the test-retest reproducibility of FDG-PET scan [ Time Frame: Reproducibility will be assessed based on the two FDG-PET scans at baseline. ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	January 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Gemcitabine will be administered intravenously at a dose of 1000-1250 mg/m2 on Day 1 and Day 8 of each cycle. Two cycles will be given 3 weeks apart. Dose adjustments based on toxicity will be allowed

cisplatin will be administered intravenously at 60-85 mg/m2 on Day 1 of each cycle. Two cycles will be given 3 weeks apart. Dose adjustments based on toxicity will be allowed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
Patient has measurable disease
Patient has not been previously treated with surgery, radiation or chemotherapy
Patient is 18 years of age or older
Patient has a performance status of 0-1 on ECOG scale
Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

Patient is taking part in another clinical study
Patient has untreated brain metastases
Patient has had radiotherapy or thoracic surgery within 3 months prior to entering the study
Patient abuses drugs or alcohol
Patient is pregnant or breastfeeding
Subject is HIV positive
Patient has active hepatitis
Patient has hearing loss
Patient has poorly controlled diabetes mellitus
Patient is allergic to gemcitabine or cisplatin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599755

Contacts

Contact: Toll Free Number

1-888-577-8839

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_662
Study First Received:	January 7, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00599755
Health Authority:	Spain: Ministry of Health

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009