Trial Outcomes & Findings for Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer (NCT NCT00410826)

Last Updated: 2013-05-10

Results Overview

Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

204 participants

Primary outcome timeframe

12 weeks after the completion of therapy

Results posted on

2013-05-10

Participant Flow

Patients were randomized between December 2006 and October 2011.

Participant milestones

Participant milestones
Measure	Arm A (Cisplatin and Radiotherapy) Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.	Arm B (Cisplatin, Radiotherapy, Erlotinib) Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
Overall Study STARTED	105	99
Overall Study COMPLETED	96	95
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Cisplatin and Radiotherapy) n=104 Participants Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.	Arm B (Cisplatin, Radiotherapy, Erlotinib) n=99 Participants Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.	Total n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	86 Participants n=7 Participants	177 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age Continuous	57 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	8 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	91 Participants n=7 Participants	175 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants	99 participants n=7 Participants	203 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the completion of therapy

Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).

Outcome measures

Outcome measures
Measure	Arm A (Cisplatin and Radiotherapy) n=96 Participants Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.	Arm B (Cisplatin, Radiotherapy, Erlotinib) n=95 Participants Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm	42 percentage of participants	51 percentage of participants

SECONDARY outcome

Timeframe: 30 days after the completion of therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 months for up to 5 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Arm A (Cisplatin and Radiotherapy) n=104 Participants Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.	Arm B (Cisplatin, Radiotherapy, Erlotinib) n=99 Participants Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride	25 participants	29 participants

Adverse Events

Arm A (Cisplatin and Radiotherapy)

Serious events: 32 serious events

Other events: 87 other events

Deaths: 0 deaths

Arm B (Cisplatin, Radiotherapy, Erlotinib)

Serious events: 38 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm A (Cisplatin and Radiotherapy) n=96 participants at risk Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.	Arm B (Cisplatin, Radiotherapy, Erlotinib) n=95 participants at risk Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
Skin and subcutaneous tissue disorders dermatitis, rash	10.4% 10/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	68.4% 65/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Gastrointestinal disorders pain	56.2% 54/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	52.6% 50/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Gastrointestinal disorders mucositis, nausea, vomiting, dehydration	32.3% 31/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	29.5% 28/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Blood and lymphatic system disorders Cytopenias	24.0% 23/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	14.7% 14/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.

Additional Information

Renato G. Martins, MD, MPH

University of Washington

Phone: 2062882048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A (Cisplatin and Radiotherapy) n=96 participants at risk Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.	Arm B (Cisplatin, Radiotherapy, Erlotinib) n=95 participants at risk Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
Ear and labyrinth disorders hearing loss	2.1% 2/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	0.00% 0/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Blood and lymphatic system disorders Cytopenias	2.1% 2/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	1.1% 1/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Gastrointestinal disorders nausea,vomiting, dehydration	7.3% 7/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	16.8% 16/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Gastrointestinal disorders mucositis, esophagitis	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	2.1% 2/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Gastrointestinal disorders peritonitis, perforation	2.1% 2/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	1.1% 1/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Metabolism and nutrition disorders hyponatremia	2.1% 2/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	1.1% 1/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Metabolism and nutrition disorders elevated creatinine	3.1% 3/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	5.3% 5/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Infections and infestations pneumonia	2.1% 2/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	3.2% 3/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Vascular disorders Pulmonary embolism, deep vein thrombosis	3.1% 3/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	2.1% 2/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Psychiatric disorders mood alteration	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	1.1% 1/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Psychiatric disorders Substance abuse, seizure	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	2.1% 2/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Cardiac disorders congestive heart disease, cardiac arrest	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	3.2% 3/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Respiratory, thoracic and mediastinal disorders Respiratory arrest, hypoxia	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	2.1% 2/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Renal and urinary disorders renal failure	2.1% 2/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	0.00% 0/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Cardiac disorders tachycardia	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	0.00% 0/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
Respiratory, thoracic and mediastinal disorders pharyngeal hemorrhage	1.0% 1/96 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.	0.00% 0/95 • Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy. All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.