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

This study has been terminated.
(Interim results of another trial showed inferior activity of treatment)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00447421
First received: March 12, 2007
Last updated: October 24, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Carcinoma, Small Cell
SCLC
Drug: pemetrexed
Drug: cisplatin
Radiation: radiation
Phase 1
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 I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 1: Best Overall Response [ Time Frame: baseline to measured response ] [ Designated as safety issue: No ]
  • Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ] [ Designated as safety issue: No ]
  • Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447421

Locations
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
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: NCT00447421     History of Changes
Other Study ID Numbers: 11089, H3E-EW-S107
Study First Received: March 12, 2007
Results First Received: May 28, 2009
Last Updated: October 24, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 16, 2014