Trial Outcomes & Findings for Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck (NCT NCT00519077)

NCT ID: NCT00519077

Last Updated: 2016-07-01

Results Overview

The proportion of subjects that responded \[complete (CR) or partial response (PR)\], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Gefitinib Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Overall Study STARTED	44
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefitinib Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Overall Study Death	6
Overall Study Other	2

Baseline Characteristics

Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib n=44 Participants Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Age, Customized <= 62 years	26 participants n=93 Participants
Age, Customized > 62 years	18 participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	35 Participants n=93 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Eight patients were not assessable for response, six of them died prior to the evaluation of response. For the purpose of the analysis these patients were classified as having disease progression in response to therapy.

Outcome measures

Outcome measures
Measure	Gefitinib n=44 Participants Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates Response (CR or PR)	6.81 percentage of participants
Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates Stable disease (SD)	18.18 percentage of participants
Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates Progressive disease (PD)	75.00 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Progression-free survival (PFS) is the number of months during and after Gefitinib treatment during which the cancer did not get worse (progress) as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Progressive disease is associated with at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. All patients developed progressive disease or died during the 9-month observation period.

Outcome measures

Outcome measures
Measure	Gefitinib n=44 Participants Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Median Progression-free Survival Time	1.9 months Interval 1.6 to 2.2

Adverse Events

Gefitinib

Serious events: 20 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gefitinib n=44 participants at risk Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Renal and urinary disorders Acute renal failure	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Cardiac disorders Atrial fibrillation	4.5% 2/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Bleeding from tumor site	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Bleeding from unspecified region	4.5% 2/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Dehydration	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Diarrhea	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Dysphagia	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Fever	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders G-tube malfunction	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders G-tube placement	4.5% 2/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders GI bleeding	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Headache	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Hypoxia	4.5% 2/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Nausea	4.5% 2/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Neck bleeding	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Pain	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Cardiac disorders Pericardial effusion	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Pleurodesis	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Pneumonia	9.1% 4/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Retroperitoneal bleed	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Infections and infestations Sepsis	4.5% 2/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Stridor	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Subacute hemorrhage of thalamus	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Tracheitis	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Unresponsiveness	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Renal and urinary disorders Urinary tract infection	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Vomiting	2.3% 1/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).

Other adverse events

Other adverse events
Measure	Gefitinib n=44 participants at risk Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Gastrointestinal disorders Dehydration	6.8% 3/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Dysphagia	9.1% 4/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 4/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Blood and lymphatic system disorders Epistaxis	6.8% 3/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
General disorders Fatigue	6.8% 3/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Skin and subcutaneous tissue disorders Rash	15.9% 7/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).
Gastrointestinal disorders Xerostomia	6.8% 3/44 • Adverse events were recorded during the 9-month observation period (including treatment phase and follow-up).

Additional Information

Tanguy Lim-Seiwert

The University of Chicago

Phone: 773-702-2452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place