Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00494026

Purpose

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: pemetrexed Drug: carboplatin Procedure: radiotherapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Overall response rate [ Time Frame: baseline to measured response after chemotherapy and radiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: baseline to date of death from any cause, 1 year ] [ Designated as safety issue: Yes ]
Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	47
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: pemetrexed 500 mg/m2, IV, q 21 days x 2 cycles then 500 mg/m2, IV, q 21 days x 2 cycles Drug: carboplatin AUC 5, IV, q 21 days x 2 cycles then AUC 5, IV, q 21 days x 2 cycles Procedure: radiotherapy 2 Gy per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (M-F)

Detailed Description:

Two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gy per fraction, 5 fractions per week, up to a dose of 50 Gy is administered)

Eligibility

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

Criteria

Inclusion Criteria:

Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer
Measurable disease
Good performance status
Adequate bone marrow reserve, hepatic, pulmonary and renal functions

Exclusion Criteria:

Serious concomitant systemic disorder
Prior chemotherapy for this cancer and/or prior thoracic radiotherapy
Pregnancy/breast-feeding
Significant weight loss over the previous 6 weeks before study entry
Inability or unwillingness to take vitamin supplementation and corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494026

Locations

Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orbassano, Italy, 10043
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Parma, Italy, 43100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Sisto, Italy, 06156
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Terni, Italy, 05100
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poznan, Poland, 60-569
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw, Poland, 02-781
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, Spain, 28035
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palma De Mallorca, Spain, 07014
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia, Spain, 46010
United Kingdom, Hants
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Southampton, Hants, United Kingdom, SO16 6YD
United Kingdom, Surrey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guilford, Surrey, United Kingdom, GU2 7XX
United Kingdom, West Midlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wolverhampton, West Midlands, United Kingdom, WV10 0QP

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10015, H3E-MC-S095
Study First Received:	June 27, 2007
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00494026
Health Authority:	Italy: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Spanish Agency of Medicines; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carboplatin
Carcinoma
Neuroendocrine Tumors
Folic Acid
Pemetrexed
Carcinoma, Small Cell

Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue

Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009