Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

This study has been terminated.
(Terminated due to lack of efficacy)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00475657
First received: May 16, 2007
Last updated: May 22, 2009
Last verified: May 2009

May 16, 2007
May 22, 2009
October 2007
April 2008   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Stable Disease Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Treatment tolerance
  • Toxicity evaluation
  • Overall survival evaluation
  • Progression-free survival
  • Tumor response duration
  • Stable disease rate
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00475657
11473, H3E-XM-S113
No
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