Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

Study Description

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Brief Summary:

The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.

Condition or disease	Intervention/treatment	Phase
Small Cell Lung Cancer	Drug: pemetrexed; Drug: cisplatin	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
Study Start Date :	October 2007
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	April 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A	Drug: pemetrexed; 500 mg/m2, intravenous (IV), every 21 days x 6 cycles; Other Names: LY231514; Alimta Drug: cisplatin; 75 mg/m2, intravenous (IV), every 21 days x 6 cycles

Outcome Measures

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Primary Outcome Measures :

1. Overall Response Rate [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: baseline to date of death from any cause ]
2. Progression Free Survival [ Time Frame: baseline to measured progressive disease ]
3. Duration of Response [ Time Frame: time of response to progressive disease ]
4. Stable Disease Rate [ Time Frame: baseline to measured progressive disease ]

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:

• Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
• Functional stage from 0 to 2 of the ECOG functional scale
• No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
• Previous bone marrow radiotherapy less than 25% is allowed.
• There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
• Appropriate organic function.
• Life expectancy estimated at 12 weeks minimum.
• Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
• The patient must be compliant and located close to the trial area for appropriate follow-up.
• The patient or his/her legal representative must sign an informed consent document.
• Patients must be at least 18 years of age.

Exclusion Criteria:

• Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
• Having participated in a previous pemetrexed trial.
• Mixed histologic diagnosis of SCLC and NSCLC.
• Concurrent illness.
• Having an active infection.
• Severe cardiac disease.
• Having received recently or concurrently a vaccine against yellow fever.
• Having suffered a previous malignant process other than SCLC.
• Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
• Clinically relevant fluid accumulation in the third space.
• Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.
• Concurrent administration of any other anti-tumor treatment.
• Severe renal failure.
• Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
• Inability or unwillingness to take folic acid and vitamin B12 supplements.
• Inability to take corticoids.

Contacts and Locations

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Locations

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.
Ferrol, Spain, 15405
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.
La Coruña, Spain, 15002
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.
Lugo, Spain, 27004
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.
Ourense, Spain, 15009
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.
Santiago de Compostela, Spain, 15706
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.
Vigo, Spain, 36211

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:	NCT00475657 History of Changes
Other Study ID Numbers:	11473; H3E-XM-S113
First Posted:	May 21, 2007
Results First Posted:	May 25, 2009
Last Update Posted:	May 29, 2009
Last Verified:	May 2009

Additional relevant MeSH terms:

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