Trial Outcomes & Findings for Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC) (NCT NCT00494026)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

baseline to measured response after chemotherapy and radiation

Results posted on

2009-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Pemetrexed + Carboplatin 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 Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Pemetrexed + Carboplatin 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 Study Sponsor Decision	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pemetrexed + Carboplatin n=4 Participants 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.
Age Continuous	59.85 years STANDARD_DEVIATION 9.45 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment Poland	2 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1 - Ambulatory, Restricted Strenuous Activity	4 participants n=5 Participants
Race/Ethnicity Caucasian	4 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to measured response after chemotherapy and radiation

Population: Trial was stopped too early to assess the primary endpoint.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to measured progressive disease

Population: Trial was terminated early. Results were not analyzed.

Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to date of death from any cause, 1 year

Population: Trial was terminated early. Results were not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: time of response to progressive disease

Population: Trial was terminated early. Results were not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every 21-day cycle for 4 cycles

Population: All enrolled patients who received radiotherapy.

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.

Outcome measures

Outcome measures
Measure	Pemetrexed + Carboplatin n=2 Participants 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.
Pharmacology Toxicity Cycle 3: Grade 2 Hematologic White Blood Cell	1 participants
Pharmacology Toxicity Cycle 3: Grade 1 Platelets	1 participants
Pharmacology Toxicity Cycle 3: Grade 3 Neutrophils	1 participants
Pharmacology Toxicity Cycle 3: Grade 2 Hemoglobin	1 participants
Pharmacology Toxicity Cycle 3: Grade 2 Hematocrit	1 participants
Pharmacology Toxicity Cycle 4: Grade 3 Hematologic White Blood Cell	1 participants
Pharmacology Toxicity Cycle 4: Grade 3 Platelets	1 participants
Pharmacology Toxicity Cycle 4: Grade 2 Neutrophils	1 participants
Pharmacology Toxicity Cycle 4: Grade 3 Hemoglobin	1 participants
Pharmacology Toxicity Cycle 4: Grade 3 Hematocrit	1 participants

Adverse Events

Pemetrexed + Carboplatin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pemetrexed + Carboplatin n=4 participants at risk 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.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1
Blood and lymphatic system disorders Neutropenia	50.0% 2/4 • Number of events 4
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 3
General disorders Fatigue	25.0% 1/4 • Number of events 1
General disorders Mucosal inflammation	25.0% 1/4 • Number of events 1
Infections and infestations Respiratory tract infection	25.0% 1/4 • Number of events 1
Investigations Platelet count decreased	50.0% 2/4 • Number of events 3
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60