Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin
Conditions
Keywords
squamous cell carcinoma of the skin, recurrent skin cancer, non-melanomatous skin cancer, Radiation, ZD1839, Iressa, Gefitinib
Brief summary
The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839) with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The safety of this treatment will also be studied
Detailed description
PRIMARY OBJECTIVES: I. Early progression rate (progression during ZD1839 induction). II. Feasibility of induction ZD1839 (for all patients) and concomitant ZD1839 with radiotherapy (for unresectable patients). III. Toxicities of induction ZD1839 (for all patients) and concomitant ZD1839 with radiotherapy (for unresectable patients). SECONDARY OBJECTIVES: I. Response: clinical responses to induction therapy. II. Failures: frequency and timing of local and distant failures. III. Biomarkers: biomarker levels in tumor and normal tissue. TERTIARY OBJECTIVES: I. For progressive disease responders, patients will be followed for locoregional and distant metastases data. II. Feasibility of maintenance ZD1839. III. Toxicities of maintenance ZD1839. OUTLINE: Patients are assigned to 1 of 2 groups. STRATUM I (initially resectable tumor): Patients undergo radiotherapy once daily (QD) 5 days a week for approximately 6-7 weeks. Patients also receive gefitinib orally (PO) QD for up to 12 months STRATUM II (initially unresectable tumor): Patients undergo radiotherapy QD 5 days a week for approximately 6-7 weeks. Patients also receive concurrent gefitinib PO QD for 6-7 weeks. Patients then undergo surgery. After surgery, patients receive gefitinib PO QD for up to 12 months. After completion of study treatment, patients are followed up for up to 5 years.
Interventions
DRUGGefitinib
Oral Gefitinib induction therapy given daily for 2 months at 250 mg/day, once a day for 30 days (1 cycle = 30 days) with at least 2 cycles of treatment (60 days) given. After 2 months evaluate for clinical response (15 days) and resectability (60 days). If after 15 days with no tumor response, daily dose doubled (500 mg), and discontinuation if tumor progression.
RADIATIONRadiotherapy
Undergo radiation therapy treatments once a day Monday through Friday for about 7 weeks. Each treatment takes about 15 minutes.
PROCEDUREConventional surgery
Undergo surgery
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Within 12 weeks (+/- 2 weeks) prior to study entry, patients must have histologically or cytologically confirmed squamous cell carcinoma (SCC) of skin that is either locally advanced or recurrent with measurable disease; if the biopsy was collected outside of MDACC, the MDACC Pathology Department must assess and confirm the SCC diagnosis * Patients may have previous surgical intervention with residual or recurrent disease * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Leukocytes \>= 3,000/mm\^3 * Absolute neutrophil count \>= 1,500/mm\^3 * Platelets \>= 100,000/mm\*3 * Total bilirubin within normal institutional limits * aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) =\< 2.5 \* institutional upper limit of normal * Creatinine within normal institutional limits OR; creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Tumors must be at least 2 cms in size or have histological or cytological verification of muscle, bone, lymph node metastasis, or perineural involvement, as measured by the treating physician(s) or National principal investigator (PI) * Negative serum pregnancy test for women of child-bearing potential (performed within 14 days, +/- 1 day, prior to start of treatment); women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician(s) immediately * Ability to understand and the willingness to sign a written Informed Consent Document (ICD); in the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MD Anderson's Policy For Consenting Non-English Speaking Participants
Exclusion criteria
* Patients who have previous radiotherapy to the proposed site of skin cancer * Patients with active cancers other than skin * Patients currently receiving any other investigational agents at time of study enrollment; patients may have received investigational agents in the past; no washout time period is required * Patients with a history of brain metastases must be excluded from this clinical study because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 * Age less than 18 years * Presence of uncontrolled intercurrent illness (co-morbid conditions) that would limit compliance with study requirements including , but not limited to, ongoing or active infection requiring parenteral antibiotics at time of study registration, symptomatic congestive heart failure (NYHA class II or greater), unstable angina pectoris or cardiac arrhythmia requiring maintenance medication * Pregnant women are excluded from this study because ZD1839 is a signal transduction inhibitor agent with the potential for teratogenic or abortifacient effects; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZD1839, breastfeeding should be discontinued if the mother is treated with ZD1839 * Patients with known immune deficiency are at an increased risk when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded due to the possible pharmacokinetic interactions with ZD1839; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * CYP3A4 inducing agents; patients receiving the following CYP3A4 inducing agents will be excluded; these include: carbamazepine, ethosuximide, griseofulvin, modafinil, nafcillin, oxcarbazepine, Phenobarbital, phenylbutazone, phenytoin, rifampin, rifabutin, St. John's Wort, and sulfinpyrazone * Patients with distant metastatic disease as determined by diagnostic imaging (i.e., chest x-rays) and/or hematologic assessments (i.e., liver enzymes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Progression Rate | Baseline to 60 days, up to 2 courses of induction therapy | Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment. |
| Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Up to 100 days | Completion Induction phase, participants are evaluated for clinical response and resectability. Resectable participants who had achieved at least stable disease and received surgery followed by radiation. Unresectable participants who had achieved at least stable disease received concomitant radiation/Gefitinib. |
| Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Up to 5 years | Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included. |
| Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Up to 5 years | Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) | Up to 5 years | Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): \>/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques. |
| Frequency and Timing of Local and Distant Failures | From study entry to first documented local recurrence or last patient contact, assessed up to 5 years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression | Baseline | Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. In addition, some participants presented with regional recurrences, which were not superficially accessible. The sample size was too small to determine the EGFR-proliferative responses activated by the AKT pathway; hence, the monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: April 08, 2005 to March 13, 2008. All participants were recruited at the University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment details
Of the 23 participants enrolled, one participant who was not evaluable for response withdrew before beginning treatment and is included the study demographics.
Participants by arm
| Arm | Count |
|---|---|
| Gefitinib, Radiotherapy, Surgery Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Progressive Disease | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gefitinib, Radiotherapy, Surgery |
|---|---|
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 5 / 22 |
Outcome results
Primary
Early Progression Rate
Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.
Time frame: Baseline to 60 days, up to 2 courses of induction therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Early Progression Rate | 31.8 percentage of participants |
Primary
Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation.
Completion Induction phase, participants are evaluated for clinical response and resectability. Resectable participants who had achieved at least stable disease and received surgery followed by radiation. Unresectable participants who had achieved at least stable disease received concomitant radiation/Gefitinib.
Time frame: Up to 100 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Complete Response (CR) | 4 Participants |
| Gefitinib, Radiotherapy, Surgery | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Stable Disease (SD) | 5 Participants |
| Gefitinib, Radiotherapy, Surgery | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Partial Response (PR) | 5 Participants |
| Gefitinib, Radiotherapy, Surgery | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Progressive Disease (PD) | 3 Participants |
| Patients Received the Escalated Gefitinib Dose | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Complete Response (CR) | 1 Participants |
| Patients Received the Escalated Gefitinib Dose | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Progressive Disease (PD) | 2 Participants |
| Patients Received the Escalated Gefitinib Dose | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Stable Disease (SD) | 3 Participants |
| Patients Received the Escalated Gefitinib Dose | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Partial Response (PR) | 0 Participants |
| Patients Treated Radiation and Concurrent Gefitinib | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Progressive Disease (PD) | 0 Participants |
| Patients Treated Radiation and Concurrent Gefitinib | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Stable Disease (SD) | 1 Participants |
| Patients Treated Radiation and Concurrent Gefitinib | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Partial Response (PR) | 2 Participants |
| Patients Treated Radiation and Concurrent Gefitinib | Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. | Complete Response (CR) | 0 Participants |
Primary
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)
Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.
Time frame: Up to 5 years
Population: Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose \& 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry eyes | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Diarrhea | 10 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Anorexia | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/desquamation | 4 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry skin | 2 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/acneiform | 7 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Abdominal pain | 2 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Ocular/visual, other | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of Creatinine | 2 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of asparagine transferase (AST) | 4 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Fatigue | 11 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of alanine transferase (ALT) | 3 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Vomiting | 3 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Nausea | 6 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Pruitis | 4 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Diarrhea | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry skin | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of asparagine transferase (AST) | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Ocular/visual, other | 1 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Pruitis | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/desquamation | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/acneiform | 4 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Anorexia | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Fatigue | 5 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Nausea | 1 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Vomiting | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of alanine transferase (ALT) | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of Creatinine | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Abdominal pain | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry eyes | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Abdominal pain | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Diarrhea | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Nausea | 3 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry skin | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Vomiting | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Fatigue | 3 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of alanine transferase (ALT) | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of asparagine transferase (AST) | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Ocular/visual, other | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry eyes | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/desquamation | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of Creatinine | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/acneiform | 2 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Anorexia | 3 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Pruitis | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Ocular/visual, other | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/acneiform | 4 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Diarrhea | 6 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry skin | 3 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Abdominal pain | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of asparagine transferase (AST) | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Nausea | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Pruitis | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Anorexia | 3 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Dry eyes | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Vomiting | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Fatigue | 2 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of Creatinine | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Rash/desquamation | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) | Elevation of alanine transferase (ALT) | 0 participants |
Primary
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)
Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.
Time frame: Up to 5 years
Population: Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose \& 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Insomnia | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Infection | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Anemia | 3 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Blurred vision | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated White Blood Cell Count (CBC) | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated BUN | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Tooth pain | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Weight Loss | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Allergic reaction | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Alopecia | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Depression | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Taste alteration | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Epistaxis | 1 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Blurred vision | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Depression | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Infection | 1 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Insomnia | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Alopecia | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated BUN | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Anemia | 1 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated White Blood Cell Count (CBC) | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Allergic reaction | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Tooth pain | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Epistaxis | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Taste alteration | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Weight Loss | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Tooth pain | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Allergic reaction | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Anemia | 2 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Weight Loss | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Alopecia | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Taste alteration | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Epistaxis | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Infection | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated BUN | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated White Blood Cell Count (CBC) | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Blurred vision | 1 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Insomnia | 0 participants |
| Patients Treated Radiation and Concurrent Gefitinib | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Depression | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Anemia | 3 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Blurred vision | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Epistaxis | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Taste alteration | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Allergic reaction | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Insomnia | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Alopecia | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Weight Loss | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Tooth pain | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated BUN | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Depression | 1 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Elevated White Blood Cell Count (CBC) | 0 participants |
| Maintenance | Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) | Infection | 0 participants |
Secondary
Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)
Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): \>/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.
Time frame: Up to 5 years
Population: One participant of 23 enrolled withdrew prior to treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) | Complete Response (CR) | 4 participants |
| Gefitinib, Radiotherapy, Surgery | Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) | Partial Response (PR) | 6 participants |
| Gefitinib, Radiotherapy, Surgery | Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) | Stable Disease (SD) | 5 participants |
| Gefitinib, Radiotherapy, Surgery | Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) | Progressive Disease (PD) | 7 participants |
Secondary
Frequency and Timing of Local and Distant Failures
Time frame: From study entry to first documented local recurrence or last patient contact, assessed up to 5 years
Population: Two participants did not complete study treatment (Surgery + Radiotherapy) of 17 progressed and was removed from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | Died of their disease (DOD) | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | Died from other causes | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | Local recurrence | 2 participants |
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | unknown | 1 participants |
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | Dermal metastases | 0 participants |
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | No Evidence of Disease (NED) | 12 participants |
| Gefitinib, Radiotherapy, Surgery | Frequency and Timing of Local and Distant Failures | Living with disease | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | Died of their disease (DOD) | 2 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | Dermal metastases | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | Died from other causes | 3 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | Living with disease | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | Local recurrence | 0 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | No Evidence of Disease (NED) | 5 participants |
| Patients Received the Escalated Gefitinib Dose | Frequency and Timing of Local and Distant Failures | unknown | 5 participants |
Other Pre-specified
Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression
Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. In addition, some participants presented with regional recurrences, which were not superficially accessible. The sample size was too small to determine the EGFR-proliferative responses activated by the AKT pathway; hence, the monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed.
Time frame: Baseline
Population: Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. Sample size was too small to determine EGFR-proliferative responses activated by the AKT pathway;hence, monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed.
Post Hoc
Participant Treatment Following Induction Therapy
Treatment received following two 30-day cycles (60 days) of 250 mg gefitinib given by mouth daily. Participant treatment reported as percentage of total treated participants out of total treated.
Time frame: Following 60 days of Gefitinib induction treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gefitinib, Radiotherapy, Surgery | Participant Treatment Following Induction Therapy | Surgery Alone | 11.8 percentage of participants |
| Gefitinib, Radiotherapy, Surgery | Participant Treatment Following Induction Therapy | Definitive Radiation | 17.6 percentage of participants |
| Gefitinib, Radiotherapy, Surgery | Participant Treatment Following Induction Therapy | Radiation and Concurrent Gefitinib | 11.8 percentage of participants |
| Gefitinib, Radiotherapy, Surgery | Participant Treatment Following Induction Therapy | Surgery, Post-Op Radiation & Concurrent Gefitinib | 47 percentage of participants |