Trial Outcomes & Findings for Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer (NCT NCT00417248)
NCT ID: NCT00417248
Last Updated: 2016-07-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
18 months
Results posted on
2016-07-25
Participant Flow
Participant milestones
| Measure |
Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
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|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
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|---|---|
|
Overall Study
Study Terminated
|
6
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib
n=8 Participants
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
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|---|---|
|
Age, Continuous
|
66.50 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The primary objective for this study was not analyzed due to termination of the study. No participants were on-study for a sufficient period of time to collect or analyze the time to disease progression data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
Outcome measures
Outcome data not reported
Adverse Events
Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib
n=8 participants at risk
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
Other adverse events
| Measure |
Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib
n=8 participants at risk
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
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|---|---|
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Investigations
ALKALINE PHOSPHATASE
|
12.5%
1/8 • Number of events 2 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY - OTHER
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
ANOREXIA
|
62.5%
5/8 • Number of events 5 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
CONSTIPATION
|
37.5%
3/8 • Number of events 3 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
50.0%
4/8 • Number of events 4 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Investigations
CREATININE
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
DEHYDRATION
|
37.5%
3/8 • Number of events 4 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
DIARRHEA
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Nervous system disorders
DIZZINESS
|
25.0%
2/8 • Number of events 2 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
62.5%
5/8 • Number of events 6 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
37.5%
3/8 • Number of events 4 • Duration of OnStudy time, up to two 28 day cycles.
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
75.0%
6/8 • Number of events 8 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
37.5%
3/8 • Number of events 7 • Duration of OnStudy time, up to two 28 day cycles.
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
General disorders
INSOMNIA
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
25.0%
2/8 • Number of events 2 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ESOPHAGUS
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
NAUSEA
|
62.5%
5/8 • Number of events 5 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
25.0%
2/8 • Number of events 2 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
PAIN / ESOPHAGUS
|
37.5%
3/8 • Number of events 3 • Duration of OnStudy time, up to two 28 day cycles.
|
|
General disorders
PAIN / HEAD/HEADACHE
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Blood and lymphatic system disorders
PLATELETS
|
25.0%
2/8 • Number of events 3 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
12.5%
1/8 • Number of events 1 • Duration of OnStudy time, up to two 28 day cycles.
|
|
Gastrointestinal disorders
VOMITING
|
37.5%
3/8 • Number of events 4 • Duration of OnStudy time, up to two 28 day cycles.
|
|
General disorders
WEIGHT LOSS
|
62.5%
5/8 • Number of events 5 • Duration of OnStudy time, up to two 28 day cycles.
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place