Trial Outcomes & Findings for Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT00726986)
NCT ID: NCT00726986
Last Updated: 2014-11-19
Results Overview
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1-year
Results posted on
2014-11-19
Participant Flow
A total of 18 patients were enrolled into the trial from 3 sites between August 2008 and November 2011. Patients were recruited from University Hospitals Case Medical Center and Cleveland Clinic in Cleveland Ohio and Columbia Presbyterian in New York.
Participant milestones
| Measure |
Sorafenib, Cisplatin, and Etoposide
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Induction Phase
STARTED
|
18
|
|
Induction Phase
Maintance
|
3
|
|
Induction Phase
COMPLETED
|
3
|
|
Induction Phase
NOT COMPLETED
|
15
|
|
Maintenance Phase
STARTED
|
3
|
|
Maintenance Phase
COMPLETED
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sorafenib, Cisplatin, and Etoposide
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Induction Phase
Adverse Event
|
4
|
|
Induction Phase
Withdrawal by Subject
|
2
|
|
Induction Phase
Death
|
2
|
|
Induction Phase
Lack of Efficacy
|
5
|
|
Induction Phase
Secondary Disease
|
2
|
|
Maintenance Phase
Adverse Event
|
1
|
|
Maintenance Phase
Lack of Efficacy
|
2
|
Baseline Characteristics
Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=18 Participants
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-yearPopulation: Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Outcome measures
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=16 Participants
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Progression-free Survival(PFS)
|
5.1 months
Interval 1.2 to 8.2
|
SECONDARY outcome
Timeframe: 1-yearPopulation: Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.
Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.
Outcome measures
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=16 Participants
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Median Overall Survival
|
7.4 months
Interval 2.5 to 10.2
|
SECONDARY outcome
Timeframe: reevaluated for response every 8 weeksPopulation: Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.
The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=17 Participants
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Response Rate
Complete Response (CR)
|
1 participants
|
|
Response Rate
Partial Response (PR)
|
7 participants
|
|
Response Rate
Stable Disease (SD)
|
1 participants
|
|
Response Rate
Progressive Disease (PD)
|
8 participants
|
SECONDARY outcome
Timeframe: Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.Population: Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.
Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.
Outcome measures
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=17 Participants
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Safety
|
14 participants
|
Adverse Events
Sorafenib, Cisplatin, and Etoposide
Serious events: 14 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=17 participants at risk
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Investigations
Creatinine
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Dehydration
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Peripheral arterial ischemia
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Platelets
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Renal and urinary disorders
Renal/Genitourinary- Glomerular Filtration Rate
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Renal and urinary disorders
Renal/Genitourinary
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Pain, Oral Cavity
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
General disorders
Dizziness
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Thrombosis
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
Other adverse events
| Measure |
Sorafenib, Cisplatin, and Etoposide
n=17 participants at risk
Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Investigations
Weight loss
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Creatinine
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Phosphate
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Infections and infestations
Infection
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Anorexia
|
47.1%
8/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
23.5%
4/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
23.5%
4/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Constipation
|
35.3%
6/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
52.9%
9/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Dehydration
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
35.3%
6/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Nervous system disorders
Dizziness
|
35.3%
6/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.5%
4/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
47.1%
8/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
General disorders
Edema-limbs
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
64.7%
11/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Flatulence
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
47.1%
8/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
58.8%
10/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
52.9%
9/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Hot flashes/flushes
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Hypertension
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Vascular disorders
Hypotension
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Psychiatric disorders
Insomnia
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
47.1%
8/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
41.2%
7/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Psychiatric disorders
Mood alteration - Depression
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Mucositis/stomatitis - Oral cavity
|
35.3%
6/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Nausea
|
58.8%
10/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Nervous system disorders
Neuropathy: sensory
|
23.5%
4/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
58.8%
10/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
23.5%
4/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest/thorax NOS
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Pain - Extremity-limb
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Nervous system disorders
Pain - Head/headache
|
35.3%
6/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
General disorders
Pain - Pelvis
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Blood and lymphatic system disorders
Platelets
|
47.1%
8/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
29.4%
5/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
General disorders
Rigors/chills
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
41.2%
7/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
17.6%
3/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
|
Eye disorders
Vision-blurred vision
|
11.8%
2/17 • Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place