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

• ClinicalTrials.gov Identifier: NCT00494026
• Recruitment Status: Terminated
• First Posted: June 29, 2007
• Results First Posted: November 17, 2009
• Last Update Posted: November 20, 2009
• Sponsor: Eli Lilly and Company
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Pemetrexed + Carboplatin
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.

Baseline Characteristics

Arm/Group Title		Pemetrexed + Carboplatin
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
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

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])
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

Outcome Measure Data

Analysis Population Description

Trial was stopped too early to assess the primary endpoint.

Arm/Group Title	Pemetrexed + Carboplatin
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
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

Outcome Measure Data

Analysis Population Description

Trial was terminated early. Results were not analyzed.

Arm/Group Title	Pemetrexed + Carboplatin
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
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

Outcome Measure Data

Analysis Population Description

Trial was terminated early. Results were not analyzed.

Arm/Group Title	Pemetrexed + Carboplatin
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
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

Outcome Measure Data

Analysis Population Description

Trial was terminated early. Results were not analyzed.

Arm/Group Title	Pemetrexed + Carboplatin
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
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

Outcome Measure Data

Analysis Population Description

All enrolled patients who received radiotherapy.

Arm/Group Title	Pemetrexed + Carboplatin
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Pemetrexed + Carboplatin
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	--/--
Serious Adverse Events
	Pemetrexed + Carboplatin
	Affected / at Risk (%)	# Events
Total	0/4 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Chief Medical Officer
• Organization: Eli Lilly and Company
• Phone: 800-545-5979

• 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