Carcinoma, Small Cell, SCLC, Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGpemetrexed
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
DRUGcisplatin
Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
RADIATIONradiation
Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Maximum Tolerated Dose | every cycle | — |
| Phase 2: Overall Response Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Time to Progressive Disease | 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. |
| Phase 1: Best Overall Response | 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. |
| Phase 2: Overall Survival | 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. |
| Phase 2: 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. |
| Phase 2: Complete Response Rate | 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. |
Countries
Belgium, Netherlands
Participant flow
Pre-assignment details
This was a Phase 1/2 trial that was terminated during Phase 1 and never progressed to Phase 2. The number of patients enrolled is for the Phase 1 portion.
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed + Cisplatin Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4 | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Sponsor Decision | 2 |
Baseline characteristics
| Characteristic | Pemetrexed + Cisplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment Belgium | 2 participants |
| Region of Enrollment Netherlands | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / — |
| serious Total, serious adverse events | 6 / — |
Outcome results
Primary
Phase 1: Maximum Tolerated Dose
Time frame: every cycle
Population: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).
Primary
Phase 2: Overall Response Rate
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 progressive disease
Population: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Secondary
Phase 1: Best Overall 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.
Time frame: baseline to measured response
Population: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.
Secondary
Phase 2: Complete Response Rate
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.
Time frame: baseline to measured response time
Population: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Secondary
Phase 2: 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: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Secondary
Phase 2: Overall Survival
Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.
Time frame: baseline to date of death from any cause
Population: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Secondary
Phase 2: Time to 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.
Time frame: baseline to measured progressive disease
Population: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.