Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.
Interventions
DRUGpemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
DRUGcisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles
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 or cytologic diagnosis of Small Cell Lung Cancer (SCLC). * Functional stage from 0 to 2 of the ECOG functional scale * No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC. * Previous bone marrow radiotherapy less than 25% is allowed. * There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria. * Appropriate organic function. * Life expectancy estimated at 12 weeks minimum. * Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment. * The patient must be compliant and located close to the trial area for appropriate follow-up. * The patient or his/her legal representative must sign an informed consent document. * Patients must be at least 18 years of age.
Exclusion criteria
* Having received treatment for the last 30 days with a drug that has not obtained regulatory approval. * Having participated in a previous pemetrexed trial. * Mixed histologic diagnosis of SCLC and NSCLC. * Concurrent illness. * Having an active infection. * Severe cardiac disease. * Having received recently or concurrently a vaccine against yellow fever. * Having suffered a previous malignant process other than SCLC. * Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed. * Clinically relevant fluid accumulation in the third space. * Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion. * Concurrent administration of any other anti-tumor treatment. * Severe renal failure. * Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents. * Inability or unwillingness to take folic acid and vitamin B12 supplements. * Inability to take corticoids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | baseline to measured progressive disease | Trial terminated - results not analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | baseline to date of death from any cause | Trial terminated - results not analyzed |
| Progression Free Survival | baseline to measured progressive disease | Trial terminated - results not analyzed |
| Duration of Response | time of response to progressive disease | Trial terminated - results not analyzed |
| Stable Disease Rate | baseline to measured progressive disease | Trial terminated - results not analyzed |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Sponsor's Decision | 3 |
Baseline characteristics
| Characteristic | Pemetrexed + Cisplatin |
|---|---|
| Age Continuous | 66.6 years STANDARD_DEVIATION 5.9 |
| Height | 163.9 centimeters STANDARD_DEVIATION 4.2 |
| Race/Ethnicity Caucasian | 5 participants |
| Region of Enrollment Spain | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
| Weight | 76.0 kilograms STANDARD_DEVIATION 5.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / — |
| serious Total, serious adverse events | 2 / — |
Outcome results
Primary
Overall Response Rate
Trial terminated - results not analyzed
Time frame: baseline to measured progressive disease
Secondary
Duration of Response
Trial terminated - results not analyzed
Time frame: time of response to progressive disease
Secondary
Overall Survival
Trial terminated - results not analyzed
Time frame: baseline to date of death from any cause
Secondary
Progression Free Survival
Trial terminated - results not analyzed
Time frame: baseline to measured progressive disease
Secondary
Stable Disease Rate
Trial terminated - results not analyzed
Time frame: baseline to measured progressive disease