Trial Outcomes & Findings for Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection (NCT NCT01927744)
NCT ID: NCT01927744
Last Updated: 2025-11-26
Results Overview
Major Pathologic Response (MPR) was defined as ≤ 10% residual biable tumor cells in the resected primary tumor specimen following completion of neadjuvant therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).
Results posted on
2025-11-26
Participant Flow
Patients with suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition) are enrolled. Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. Must be age ≥ 18 years. ECOG PS ≤ 2 (Appendix C) and adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L.
A total of 55 participants were enrolled. Three participants did not proceed to randomization: two were screen failures and one was lost to follow-up prior to treatment initiation. The remaining 52 participants were randomized.
Participant milestones
| Measure |
Chemotherapy + Erlotinib
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Chemotherapy + Placebo
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
28
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
| Measure |
Chemotherapy + Erlotinib
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Chemotherapy + Placebo
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
|---|---|---|
|
Overall Study
Death
|
2
|
9
|
Baseline Characteristics
Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection
Baseline characteristics by cohort
| Measure |
Chemotherapy + Erlotinib
n=24 Participants
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Chemotherapy + Placebo
n=28 Participants
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=492 Participants
|
57 years
n=492 Participants
|
58 years
n=984 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=492 Participants
|
11 Participants
n=492 Participants
|
21 Participants
n=984 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=492 Participants
|
17 Participants
n=492 Participants
|
31 Participants
n=984 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
5 Participants
n=984 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=492 Participants
|
22 Participants
n=492 Participants
|
41 Participants
n=984 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
5 Participants
n=984 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=492 Participants
|
28 participants
n=492 Participants
|
52 participants
n=984 Participants
|
PRIMARY outcome
Timeframe: At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).Major Pathologic Response (MPR) was defined as ≤ 10% residual biable tumor cells in the resected primary tumor specimen following completion of neadjuvant therapy.
Outcome measures
| Measure |
Chemotherapy + Erlotinib
n=23 Participants
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Chemotherapy + Placebo
n=24 Participants
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
|---|---|---|
|
Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis)
|
7 participants
|
10 participants
|
Adverse Events
Chemotherapy + Erlotinib
Serious events: 8 serious events
Other events: 23 other events
Deaths: 2 deaths
Chemotherapy + Placebo
Serious events: 10 serious events
Other events: 27 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Chemotherapy + Erlotinib
n=24 participants at risk
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Chemotherapy + Placebo
n=28 participants at risk
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
0.00%
0/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Cardiac disorders
Cardiac
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
0.00%
0/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Blood and lymphatic system disorders
Cytopenia
|
8.3%
2/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
7.1%
2/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
0.00%
0/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Fatigue
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
17.9%
5/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Gastrointestinal disorders
Gastroninstenal Disorders
|
12.5%
3/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
7.1%
2/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Ear and labyrinth disorders
Hearing
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
0.00%
0/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Infections and infestations
Infection
|
8.3%
2/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
3.6%
1/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Metabolism and nutrition disorders
Metabolic and Nutrition
|
25.0%
6/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
3.6%
1/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
20.8%
5/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
7.1%
2/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Other
|
4.2%
1/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
7.1%
2/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Pain
|
4.2%
1/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
7.1%
2/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
0.00%
0/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Any AE
|
33.3%
8/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
35.7%
10/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
Other adverse events
| Measure |
Chemotherapy + Erlotinib
n=24 participants at risk
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
Chemotherapy + Placebo
n=28 participants at risk
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Phone Call: Phone call made to patient 1 time each year after the end of treatment visit.
Chemotherapy: Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Cytopenia
|
37.5%
9/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
17.9%
5/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Nervous system disorders
Dizziness
|
45.8%
11/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
21.4%
6/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Fatigue
|
79.2%
19/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
57.1%
16/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Gastrointestinal disorders
Gastroninstenal Disorders
|
66.7%
16/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
71.4%
20/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Ear and labyrinth disorders
Hearing
|
0.00%
0/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
10.7%
3/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Infections and infestations
Infection
|
41.7%
10/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
14.3%
4/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Metabolism and nutrition disorders
Metabolic and Nutrition
|
37.5%
9/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
28.6%
8/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
66.7%
16/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
53.6%
15/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Other
|
66.7%
16/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
50.0%
14/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Pain
|
33.3%
8/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
53.6%
15/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Rash
|
79.2%
19/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
50.0%
14/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
General disorders
Any AE
|
95.8%
23/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
96.4%
27/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Cardiac disorders
Cardiac
|
16.7%
4/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
3.6%
1/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.8%
11/24 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
53.6%
15/28 • Up to 9 weeks (from initiation of induction chemotherapy through surgery).
MedDRA v12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place