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
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: pemetrexed
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475657

Locations
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
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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00475657     History of Changes
Other Study ID Numbers: 11473, H3E-XM-S113
Study First Received: May 16, 2007
Results First Received: March 31, 2009
Last Updated: May 22, 2009
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 01, 2014