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

October 24, 2009 updated by: Eli Lilly and Company

Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • 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.
  • Netherlands
      • 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
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Alimta
  • LY231514
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Maximum Tolerated Dose
Time Frame: every cycle
every cycle
Phase 2: Overall Response Rate
Time Frame: baseline to measured progressive disease
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.
baseline to measured progressive disease

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Best Overall Response
Time Frame: baseline to measured response
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; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
baseline to measured response
Phase 2: Complete Response Rate
Time Frame: baseline to measured response time
Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.
baseline to measured response time
Phase 2: Time to Progressive Disease
Time Frame: baseline to measured progressive disease
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
baseline to measured progressive disease
Phase 2: 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.
time of response to progressive disease
Phase 2: Overall Survival
Time Frame: baseline to date of death from any cause
Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.
baseline to date of death from any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 14, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2009

Last Update Submitted That Met QC Criteria

October 24, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11089
  • H3E-EW-S107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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