Trial Outcomes & Findings for Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (NCT NCT01104922)

Last Updated: 2022-02-14

Results Overview

Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

At 1-year

Results posted on

2022-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab and Stereotactic Radiosurgery Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Prior surgery	67 percentage of participants n=5 Participants
Prior chemotherapy	65 percentage of participants n=5 Participants
Received prior epidermal growth factor receptor (EGFR)	23 percentage of participants n=5 Participants
Zubrod performance status Score = 0	22 Participants n=5 Participants
Zubrod performance status Score = 1	23 Participants n=5 Participants
Zubrod performance status Score = 2	3 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1-year

Population: Patients that received study therapy and were evaluable for response to treatment.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
1-year Local Progression-free Survival (PFS)	60 percentage of participants Interval 44.0 to 75.0

PRIMARY outcome

Timeframe: At 1-year

Population: Patients that received study therapy and were evaluable for response to treatment.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
1-year Locoregional Progression-free Survival (PFS)	37 percentage of participants Interval 23.0 to 53.0

PRIMARY outcome

Timeframe: At 1-year

Population: Patients that received study therapy and were evaluable for response to treatment.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
1-year Distant Progression-free Survival (PFS)	77 percentage of participants Interval 54.0 to 85.0

SECONDARY outcome

Timeframe: At 1-year

Population: Patients that received study therapy and were evaluable for response to treatment.

Progression was defined as greater than 20% increase in the sum of the longest diameters of target lesions, per Response Evaluation Criteria in Solid Tumors (RECIST v1.0), taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
1-year Progression-free Survival (PFS)	33 percentage of participants Interval 20.0 to 49.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Patients that received study therapy.

Number of months patients remaining alive after study treatment.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Overall Survival (OS)	10 months Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Patients that received study therapy and were evaluable for response to treatment.

Response by number and percentage of patients assessed by subjective interpretation of the first PET-CT. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=48 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Overall Response (OR) Complete response	9 Participants
Overall Response (OR) Partial Response	13 Participants
Overall Response (OR) Stable disease	5 Participants
Overall Response (OR) Disease progression	17 Participants

SECONDARY outcome

Timeframe: Up to 24 months / post therapy

Population: Patients that received study therapy and were evaluable for response and by FDG PET.

Glucose metabolism was assessed by FDG PET. FDG uptake reflects the tissue glucose metabolism and is usually high in high-grade tumors and relatively low in low-grade tumors.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=44 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Changes in Tumor Glucose Metabolism Stable Disease (SD)	5 Participants
Changes in Tumor Glucose Metabolism Complete Response (CR)	9 Participants
Changes in Tumor Glucose Metabolism Partial Response (PR)	13 Participants
Changes in Tumor Glucose Metabolism Progressive Disease (PD)	17 Participants

SECONDARY outcome

Timeframe: Up to 24 months; before and after treatment

Population: At the time of this study, PMISO could not be readily obtained due to its relatively short half-life and unforeseen inability to procure this radioisotope locally. Thus, to prevent delay in treating aggressive cancer, F-MISO scans were not performed.

Changes in tumor hypoxia (tumor cells deprived of oxygen) as a result of Stereotactic radiosurgery (SRS) through assessment by pre-and post-treatment fluorodeoxyglucose (FDG)- and fluoromisonidazole (FMISO)-PET.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-8 weeks post-treatment; up to 16 months

Population: Patients that received study therapy and were able to complete Quality of Life assessments, who reported stable or improved quality of life.

Percentage of patients that reported stable and/or improved of quality of life after SBRT as indicated by a quantitative increase or maintenance in overall score. Quality of Life was assessed by longitudinal collection of the University of Washington Quality of Life Registry (UW-QoL-R) survey data, both pre- and post-SBRT. Patients completed the previously validated UW-QoL-R survey at enrollment and again after SBRT. UW-QoL-R measures patient reported QoL in 12 head and neck-specific and 3 global health domains, using a single Likert-scale question with an assigned score of 0 to 100 with 100 representing normal function.

Outcome measures

Outcome measures
Measure	Cetuximab and Stereotactic Radiosurgery n=28 Participants Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Quality of Life (QoL)	62 percentage of participants

Adverse Events

Cetuximab and Stereotactic Radiosurgery

Serious events: 3 serious events

Other events: 43 other events

Deaths: 42 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab and Stereotactic Radiosurgery n=48 participants at risk Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Gastrointestinal disorders Dysphagia	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Skin and subcutaneous tissue disorders Rash (erbiutx)	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.

Other adverse events

Other adverse events
Measure	Cetuximab and Stereotactic Radiosurgery n=48 participants at risk Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Gastrointestinal disorders Dry Mouth (Xerostomia)	16.7% 8/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Dysgeusia (Taste Alteration	8.3% 4/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Mucositis	54.2% 26/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Dysphagia	18.8% 9/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Odynphagia (Painful swallowing)	16.7% 8/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Dysphonia (difficulty speaking)	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Respiratory, thoracic and mediastinal disorders Voice Changes (hoarsenss)	4.2% 2/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
General disorders Pain	10.4% 5/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
General disorders Fatigue	10.4% 5/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Nausea	4.2% 2/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Vomiting	10.4% 5/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Skin and subcutaneous tissue disorders Rash (erbiutx)	31.2% 15/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Skin and subcutaneous tissue disorders Hyperpigmentation	12.5% 6/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Skin and subcutaneous tissue disorders Fibrosis	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Gastrointestinal disorders Stomatitis	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
Musculoskeletal and connective tissue disorders Osteonecrosis	2.1% 1/48 • Adverse events were assessed through study completion, up to 2 years. Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.

Additional Information

Barbara Stadterman, Regulatory Supervisor; ClinicalTrials.gov Admin

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place