Trial Outcomes & Findings for Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck (NCT NCT01192815)

NCT ID: NCT01192815

Last Updated: 2020-05-12

Results Overview

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. Disease progression free survival (PFS) is measured from start of treatment to the date of disease progression or protocol-designated outcome, whichever occurs first and censored at the date of last followed for those survivors without disease progression 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. Measured via Conventional CT and MRI

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

1 year and 10 months following study start

Results posted on

2020-05-12

Participant Flow

Patients recruited from local medical clinic from January 2011 through May 2012.

Participant milestones

Participant milestones
Measure	Arm I Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=2 Participants Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	2 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year and 10 months following study start

Population: One patient progressed while study was still active, study closed before follow up completed for second participant and therefore was not evaluable.

Outcome measures

Outcome measures
Measure	Arm I n=1 Participants Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression	6 months

SECONDARY outcome

Timeframe: 1 year and 10 months following study start

Population: One patient progressed while study was still active, study closed before follow up completed for second participant and therefore was not evaluable.

Number of patients with complete response, partial response, stable disease, or progressive disease. Assessed via Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Measured via conventional CT and MRI

Outcome measures

Outcome measures
Measure	Arm I n=1 Participants Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Objective Response Rate Partial response	1 Participants
Objective Response Rate Complete response	0 Participants
Objective Response Rate Stable disease	0 Participants
Objective Response Rate Progressive disease	0 Participants

SECONDARY outcome

Timeframe: 5 yrs following treatment

Population: Participants did not complete follow-up per protocol as trial was terminated early

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 yrs after treatment

Population: Participants enrolled in trial and given treatment. See AE section for details.

Number of participants who experienced adverse events (AE's) and serious adverse events (SAE's) during the course of the trial according to CTCAE (4.0)

Outcome measures

Outcome measures
Measure	Arm I n=2 Participants Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Toxicities, Number of Persons With Adverse Events	2 Participants

SECONDARY outcome

Timeframe: after treatment at 6 mos

Population: QOL was no collected and analyzed for this study due to study termination.

Quality of Life (QOL) measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 yrs following treatment

Population: Due to the low accrual no data collected.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-treatment then weekly

Population: Both participants did not complete treatment per protocol and were not evaluable. No data collected.

Determine the pharmacokinetic profile of erlotinib. Additional analyses of the pharmacokinetic data on patients receiving daily erlotinib treatment via their feeding tube will be conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 yrs post concurrent chemo-radiation therapy

Population: Both participants did not complete treatment per protocol and were not evaluable. No data collected.

Determine the effect of treatment and dose of treatment on biologic correlates in tumor tissue and/or surrounding mucosa.

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=2 participants at risk Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypoglycemia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Injury, poisoning and procedural complications Surgical and medical procedures - Other, specify	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.

Other adverse events

Other adverse events
Measure	Arm I n=2 participants at risk Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Dry mouth	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Gastrointestinal disorders Dysphagia	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Gastrointestinal disorders Nausea	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Gastrointestinal disorders Dyspepsia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Gastrointestinal disorders Mucositis oral	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Investigations Lymphocyte count decreased	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Investigations Weight loss	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Investigations Blood bilirubin increased	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Investigations Platelet count decreased	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Metabolism and nutrition disorders Anorexia	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Metabolism and nutrition disorders Hyperkalemia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Metabolism and nutrition disorders Hypernatremia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Metabolism and nutrition disorders Hypoglycemia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Metabolism and nutrition disorders Hypophosphatemia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Musculoskeletal and connective tissue disorders Neck pain	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Psychiatric disorders Insomnia	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Psychiatric disorders Agitation	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 2/2 • Adverse event data was collected from start of study over a 1 year time period.
Respiratory, thoracic and mediastinal disorders Hoarseness	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Blood and lymphatic system disorders Anemia	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Infections and infestations Mucosal infection	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Injury, poisoning and procedural complications Dermatitis radiation	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Nervous system disorders Dizziness	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Skin and subcutaneous tissue disorders Dry skin	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Skin and subcutaneous tissue disorders Rash acneiform	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 1/2 • Adverse event data was collected from start of study over a 1 year time period.

Additional Information

Panayiotis Savvides, MD

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: 216-844-5946

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place