A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

Study Description

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Brief Summary:

The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

Condition or disease	Intervention/treatment	Phase
Small Cell Lung Cancer; Carcinoma, Small Cell; SCLC	Drug: pemetrexed; Drug: cisplatin; Radiation: radiation	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Start Date :	February 2007
Actual Primary Completion Date :	May 2008
Actual Study Completion Date :	May 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A	Drug: pemetrexed; Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation) Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles; Other Names: LY231514; Alimta Drug: cisplatin; Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles Radiation: radiation; Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

Outcome Measures

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Primary Outcome Measures :

1. Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ]
2. Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :

1. Phase 1: Best Overall Response [ Time Frame: baseline to measured response ]
2. Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ]
3. Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]
4. Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ]
5. Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Measurable disease with diagnosis of Small Cell Lung Cancer.
• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
• Patients must be at least 18 years of age and have at least a 12-week life expectancy.
• No prior chemotherapy and/or prior thoracic radiotherapy.
• Adequate pulmonary function and organ function.

Exclusion Criteria:

• Patients with myocardial infarction within the preceding six months.
• Diagnosis of a serious concomitant systemic disorder.
• Prior radiotherapy to the lower neck or abdominal region.
• Significant weight loss.
• Concurrent administration of any other antitumor therapy.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Belgium
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.
Leuven, Belgium, 3000
Netherlands
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.
Amsterdam, Netherlands, 1081 HV
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.
Den Bosch, Netherlands, 5211 NL
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.
Rotterdam, Netherlands, 3075 EA

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00447421 History of Changes
Other Study ID Numbers:	11089; H3E-EW-S107
First Posted:	March 14, 2007
Results First Posted:	August 26, 2009
Last Update Posted:	October 28, 2009
Last Verified:	October 2009

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms	Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Cisplatin; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors