Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

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. 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
Information provided by:
Eli Lilly and Company

May 16, 2007
May 21, 2007
March 31, 2009
May 25, 2009
May 29, 2009
October 2007
April 2008   (Final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: baseline to measured progressive disease ]
Overall Response Rate after six cycles of combined pemetrexed plus cisplatin measured by imaging techniques (computerized tomography, nuclear magnetic resonance or thorax X-ray)
Complete list of historical versions of study NCT00475657 on Archive Site
  • Overall Survival [ Time Frame: baseline to date of death from any cause ]
  • Progression Free Survival [ Time Frame: baseline to measured progressive disease ]
  • Duration of Response [ Time Frame: time of response to progressive disease ]
  • Stable Disease Rate [ Time Frame: baseline to measured progressive disease ]
  • Treatment tolerance
  • Toxicity evaluation
  • Overall survival evaluation
  • Progression Free Survival
  • Tumor response duration
  • Stable Disease Rate
Not Provided
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Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • 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
Experimental: A
  • Drug: pemetrexed
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2009

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