Small Cell Lung Cancer
Conditions
Brief summary
This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer
Detailed description
Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray \[Gy\] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).
Interventions
DRUGpemetrexed
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
DRUGcarboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles
PROCEDUREradiotherapy
2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer * Measurable disease * Good performance status * Adequate bone marrow reserve, hepatic, pulmonary and renal functions
Exclusion criteria
* Serious concomitant systemic disorder * Prior chemotherapy for this cancer and/or prior thoracic radiotherapy * Pregnancy/breast-feeding * Significant weight loss over the previous 6 weeks before study entry * Inability or unwillingness to take vitamin supplementation and corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR]) | baseline to measured response after chemotherapy and radiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | baseline to measured progressive disease | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. |
| Overall Survival | baseline to date of death from any cause, 1 year | 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. |
| Duration of Response | 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. |
| Pharmacology Toxicity | every 21-day cycle for 4 cycles | 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. |
Countries
Italy, Poland, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sponsor Decision | 4 |
Baseline characteristics
| Characteristic | Pemetrexed + Carboplatin |
|---|---|
| Age Continuous | 59.85 years STANDARD_DEVIATION 9.45 |
| Eastern Cooperative Oncology Group Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 4 participants |
| Race/Ethnicity Caucasian | 4 participants |
| Region of Enrollment Poland | 2 participants |
| Region of Enrollment Spain | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])
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
Population: Trial was stopped too early to assess the primary endpoint.
Secondary
Duration of Response
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
Population: Trial was terminated early. Results were not analyzed.
Secondary
Overall Survival
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
Population: Trial was terminated early. Results were not analyzed.
Secondary
Pharmacology Toxicity
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
Population: All enrolled patients who received radiotherapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 3: Grade 2 Hematologic White Blood Cell | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 3: Grade 1 Platelets | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 3: Grade 3 Neutrophils | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 3: Grade 2 Hemoglobin | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 3: Grade 2 Hematocrit | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 4: Grade 3 Hematologic White Blood Cell | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 4: Grade 3 Platelets | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 4: Grade 2 Neutrophils | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 4: Grade 3 Hemoglobin | 1 participants |
| Pemetrexed + Carboplatin | Pharmacology Toxicity | Cycle 4: Grade 3 Hematocrit | 1 participants |
Secondary
Progression-free Survival
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
Population: Trial was terminated early. Results were not analyzed.