Trial Outcomes & Findings for Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo for Advanced Squamous Cell Head and Neck Cancer (NCT NCT00448240)
NCT ID: NCT00448240
Last Updated: 2025-03-18
Results Overview
Response rate of intermittent Tarceva will be measured by applying RECIST 1.0 criteria to measure response using radiologic testing.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
6 participants
Primary outcome timeframe
Evaluated at 6-week intervals, up to an average of 18 weeks.
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Erlotinib
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Erlotinib: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo for Advanced Squamous Cell Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib
n=6 Participants
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Erlotinib: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated at 6-week intervals, up to an average of 18 weeks.Response rate of intermittent Tarceva will be measured by applying RECIST 1.0 criteria to measure response using radiologic testing.
Outcome measures
| Measure |
Erlotinib
n=6 Participants
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Erlotinib: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
|
|---|---|
|
Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy
Partial Response
|
3 Participants
|
|
Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy
Stable Disease
|
2 Participants
|
|
Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy
Disease Progression
|
1 Participants
|
Adverse Events
Erlotinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Erlotinib
n=6 participants at risk
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Erlotinib: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
|
|---|---|
|
Blood and lymphatic system disorders
lymphopenia
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
anemia
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6
|
|
Ear and labyrinth disorders
hearing loss
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
16.7%
1/6
|
Additional Information
Tiffany Pearce, Director of Clinical Trials
Henry Ford Health System
Phone: 313-575-8046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place