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

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ClinicalTrials.gov Identifier: NCT00447421
Recruitment Status : Terminated (Interim results of another trial showed inferior activity of treatment)
First Posted : March 14, 2007
Results First Posted : August 26, 2009
Last Update Posted : October 28, 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 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

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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 ]
    Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.


Secondary Outcome Measures :
  1. Phase 1: Best Overall Response [ Time Frame: baseline to measured response ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

  2. Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ]
    Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.

  3. Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]
    Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.

  4. Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ]
    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

  5. Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ]
    Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.


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:

  • 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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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): NCT00447421


Locations
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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
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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: NCT00447421    
Other Study ID Numbers: 11089
H3E-EW-S107
First Posted: March 14, 2007    Key Record Dates
Results First Posted: August 26, 2009
Last Update Posted: October 28, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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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