Trial Outcomes & Findings for Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer (NCT NCT00592007)
NCT ID: NCT00592007
Last Updated: 2017-06-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
14 weeks after start of fulvestrant
Results posted on
2017-06-06
Participant Flow
Participant milestones
| Measure |
Fulvestrand and Erlotinib
Single-arm study
Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Fulvestrand and Erlotinib
Single-arm study
Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
patient ineligible (out of lab range)
|
1
|
Baseline Characteristics
Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant and Erlotinib
n=7 Participants
Single-arm study
Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeks after start of fulvestrantPopulation: Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Patients will be followed until deathPopulation: Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.
Outcome measures
Outcome data not reported
Adverse Events
A: Fulvestrant and Erlotinib
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: Fulvestrant and Erlotinib
n=7 participants at risk
Single-arm study
Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Acneiform Rash
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology - Erythema
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 4
|
|
Nervous system disorders
Pain - Arthralgia
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchorrhea
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
42.9%
3/7 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash in Groin
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Left Groin Rash
|
14.3%
1/7 • Number of events 1
|
|
Ear and labyrinth disorders
Changes in Equilibrium
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Double Vision
|
28.6%
2/7 • Number of events 2
|
|
Immune system disorders
Night Sweats
|
14.3%
1/7 • Number of events 1
|
|
Endocrine disorders
Hot Flashes
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Decreased Appetite
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Weight Loss
|
28.6%
2/7 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Draining Sinuses
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Weakness
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Cardiac Murmur
|
14.3%
1/7 • Number of events 1
|
|
Investigations
ALT Elevated
|
14.3%
1/7 • Number of events 1
|
|
Investigations
AST Elevated
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleed
|
14.3%
1/7 • Number of events 1
|
Additional Information
Lyudmila Bazhenova, MD
UC San Diego, Moores Cancer Center
Phone: 858 822 6189
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60