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Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00494026
Recruitment Status : Terminated (Study stopped early based on interim results of another trial, showing inferior activity of pemetrexed/carboplatin compared to etoposide/carboplatin in SCLC.)
First Posted : June 29, 2007
Results First Posted : November 17, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 27, 2007
First Posted Date  ICMJE June 29, 2007
Results First Submitted Date  ICMJE October 14, 2009
Results First Posted Date  ICMJE November 17, 2009
Last Update Posted Date November 20, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR]) [ Time Frame: baseline to measured response after chemotherapy and radiation ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2007)
To estimate the overall response rate after treatment with pemetrexed and carboplatin and concurrent radiation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
  • Progression-free Survival [ Time Frame: baseline to measured progressive disease ]
    Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
  • Overall Survival [ Time Frame: baseline to date of death from any cause, 1 year ]
    Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.
  • 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.
  • Pharmacology Toxicity [ Time Frame: every 21-day cycle for 4 cycles ]
    Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2007)
  • To assess progression-free survival
  • To assess 1-year overall survival
  • To assess duration of response
  • To determine complete response rate
  • To evaluate safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)
Official Title  ICMJE Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer
Brief Summary 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
Detailed Description Two 21-day cycles of pemetrexed (500 milligrams per square meter [mg/m2] intravenous [IV] infusion) and carboplatin (target area under the curve [AUC] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray [Gy] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles
    Other Names:
    • LY231514
    • Alimta
  • Drug: carboplatin
    Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles
  • Procedure: radiotherapy
    2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)
Study Arms  ICMJE Experimental: Pemetrexed + Carboplatin
Interventions:
  • Drug: pemetrexed
  • Drug: carboplatin
  • Procedure: radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 14, 2009)
4
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2007)
47
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Poland,   Spain,   United Kingdom
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT00494026
Other Study ID Numbers  ICMJE 10015
H3E-MC-S095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP