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Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT00494026
Recruitment Status : Terminated (Study stopped early based on interim results of another trial, showing inferior activity of pemetrexed/carboplatin compared to etoposide/carboplatin in SCLC.)
First Posted : June 29, 2007
Results First Posted : November 17, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Small Cell Lung Cancer
Interventions Drug: pemetrexed
Drug: carboplatin
Procedure: radiotherapy
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Period Title: Overall Study
Started 4
Completed 0 [1]
Not Completed 4
Reason Not Completed
Sponsor Decision             4
[1]
2 patients did receive the full study treatment prior to the study being terminated.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
59.85  (9.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants
Poland 2
Spain 2
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
1 - Ambulatory, Restricted Strenuous Activity Number Analyzed 4 participants
4
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 4 participants
4
1.Primary Outcome
Title Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])
Hide Description 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.
Time Frame baseline to measured response after chemotherapy and radiation
Hide Outcome Measure Data
Hide Analysis Population Description
Trial was stopped too early to assess the primary endpoint.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression-free Survival
Hide Description Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time Frame baseline to measured progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
Trial was terminated early. Results were not analyzed.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.
Time Frame baseline to date of death from any cause, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Trial was terminated early. Results were not analyzed.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Response
Hide Description 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 Frame time of response to progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
Trial was terminated early. Results were not analyzed.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pharmacology Toxicity
Hide Description Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.
Time Frame every 21-day cycle for 4 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who received radiotherapy.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Cycle 3: Grade 2 Hematologic White Blood Cell 1
Cycle 3: Grade 1 Platelets 1
Cycle 3: Grade 3 Neutrophils 1
Cycle 3: Grade 2 Hemoglobin 1
Cycle 3: Grade 2 Hematocrit 1
Cycle 4: Grade 3 Hematologic White Blood Cell 1
Cycle 4: Grade 3 Platelets 1
Cycle 4: Grade 2 Neutrophils 1
Cycle 4: Grade 3 Hemoglobin 1
Cycle 4: Grade 3 Hematocrit 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description

Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.

Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles.

All-Cause Mortality
Pemetrexed + Carboplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed + Carboplatin
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pemetrexed + Carboplatin
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Blood and lymphatic system disorders   
Anaemia  1  1/4 (25.00%)  1
Neutropenia  1  2/4 (50.00%)  4
Gastrointestinal disorders   
Nausea  1  1/4 (25.00%)  1
Vomiting  1  1/4 (25.00%)  3
General disorders   
Fatigue  1  1/4 (25.00%)  1
Mucosal inflammation  1  1/4 (25.00%)  1
Infections and infestations   
Respiratory tract infection  1  1/4 (25.00%)  1
Investigations   
Platelet count decreased  1  2/4 (50.00%)  3
Metabolism and nutrition disorders   
Anorexia  1  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00494026    
Other Study ID Numbers: 10015
H3E-MC-S095
First Submitted: June 27, 2007
First Posted: June 29, 2007
Results First Submitted: October 14, 2009
Results First Posted: November 17, 2009
Last Update Posted: November 20, 2009