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Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00475657
Recruitment Status : Terminated (Terminated due to lack of efficacy)
First Posted : May 21, 2007
Results First Posted : May 25, 2009
Last Update Posted : May 29, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

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

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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 ]
    Trial terminated - results not analyzed


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: baseline to date of death from any cause ]
    Trial terminated - results not analyzed

  2. Progression Free Survival [ Time Frame: baseline to measured progressive disease ]
    Trial terminated - results not analyzed

  3. Duration of Response [ Time Frame: time of response to progressive disease ]
    Trial terminated - results not analyzed

  4. Stable Disease Rate [ Time Frame: baseline to measured progressive disease ]
    Trial terminated - results not analyzed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475657


Locations
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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
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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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Additional Information:

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00475657    
Other Study ID Numbers: 11473
H3E-XM-S113
First Posted: May 21, 2007    Key Record Dates
Results First Posted: May 25, 2009
Last Update Posted: May 29, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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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