Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT00524121

Recruitment Status : Completed

First Posted : September 3, 2007

Results First Posted : March 5, 2015

Last Update Posted : April 14, 2016

Sponsor:

Information provided by (Responsible Party):

Roswell Park Cancer Institute

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Esophageal Cancer
Interventions	Drug: erlotinib hydrochloride Other: immunohistochemistry staining method Radiation: radiation therapy
Enrollment	22

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Erlotinib in Combination With Radiotherapy
Arm/Group Description	Erlotinib (150 mg) administered ora...
Arm/Group Description	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
Period Title: Overall Study
Started	22
Completed	3
Not Completed	19
Reason Not Completed
Disease progression	6
Adverse Event	4
Patient refused	2
Other	1
Death	1
Not treated (became ineligible)	4
Not treated (changed mind)	1

Baseline Characteristics

Arm/Group Title		Erlotinib in Combination With Radiotherapy
Arm/Group Description		Erlotinib (150 mg) administered ora...
Arm/Group Description		Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
Overall Number of Baseline Participants		17
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All Treated Patients
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	17 participants
		79.94 (6.44)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	17 participants
	Female	6 35.3%
	Male	11 64.7%

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Erlotinib in Combination With Radiotherapy
Arm/Group Description:	Erlotinib (150 mg) administered ora...
Arm/Group Description:	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
Overall Number of Participants Analyzed	17
Median (95% Confidence Interval) Unit of Measure: months
	7.3 (3.8 to 22.3)

2.Secondary Outcome


Title	Complete Response
Description	Response assessment by C...
Description	Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor.
Time Frame	4-8 weeks after completion of radiation.

Outcome Measure Data

Analysis Population Description

Patients Treated with Study Therapy


Arm/Group Title	Erlotinib in Combination With Radiotherapy
Arm/Group Description:	Erlotinib (150 mg) administered ora...
Arm/Group Description:	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
Overall Number of Participants Analyzed	17
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	11.76 (1.46 to 36.44)

3.Secondary Outcome


Title	Progresssion-Free Survival
Description	Progression is defined as at least a 20% increase in the sum of long d...
Description	Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	Every 3 months, up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Erlotinib in Combination With Radiotherapy
Arm/Group Description:	Erlotinib (150 mg) administered ora...
Arm/Group Description:	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
Overall Number of Participants Analyzed	17
Median (95% Confidence Interval) Unit of Measure: months
	4.5 (2.4 to 7.3)

4.Secondary Outcome


Title	Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale
Description	Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health...
Description	Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes
Time Frame	Baseline and Week 3

Outcome Measure Data

Analysis Population Description

Patients Treated with Study Therapy and with FACT-E scores available


Arm/Group Title	Erlotinib in Combination With Radiotherapy at Baseline	Erlotinib in Combination With Radiotherapy at Week 3
Arm/Group Description:	Erlotinib (150 mg) administered ora...	Erlotinib (150 mg) administered ora...
Arm/Group Description:	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
Overall Number of Participants Analyzed	17	14
Median (Full Range) Unit of Measure: FACT-E Score
	1.05 (.16 to 2.61)	1.36 (.51 to 2.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib in Combination With Radiotherapy at Baseline
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	Wilcoxon signed rank test
	Comments	[Not Specified]

5.Secondary Outcome


Title	Correlation of Smoking Status With Overall Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Patients Treated with Study Therapy


Arm/Group Title	Current Smokers	Former Smokers	Never Smokers
Arm/Group Description:	[Not Specified]	[Not Specified]	[Not Specified]
Arm/Group Description:	[Not Specified]	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	3	12	2
Median (95% Confidence Interval) Unit of Measure: months
	2.4 (2.4 to 7.3)	7.2 (3.8 to 42)	16.6 (10.9 to 22.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Current Smokers, Former Smokers, Never Smokers
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.115
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

6.Secondary Outcome


Title	Response by Epidermal Growth Factor Receptor (EGFR) Expression
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Radiologic evaluation every 3 months, up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	EGFR<=120 μg/ml	EGFR>120 μg/ml
Arm/Group Description:	Cut at median of 120 EGFR<=120 μg/m...	Cut at median of 120 EGFR>120 μg/ml
Arm/Group Description:	Cut at median of 120 EGFR<=120 μg/ml	Cut at median of 120 EGFR>120 μg/ml
Overall Number of Participants Analyzed	8	8
Measure Type: Number Unit of Measure: participants
Non-responder	6	5
Responder	2	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGFR<=120 μg/ml, EGFR>120 μg/ml
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.000
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

7.Secondary Outcome


Title	Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Radiologic evaluation every 3 months, up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	pEGFR<=20 μg/ml	pEGFR>20 μg/ml
Arm/Group Description:	Cut at median of 20 pEGFR<=20 μg/ml	Cut at median of 20 pEGFR>20 μg/ml
Arm/Group Description:	Cut at median of 20 pEGFR<=20 μg/ml	Cut at median of 20 pEGFR>20 μg/ml
Overall Number of Participants Analyzed	8	8
Measure Type: Number Unit of Measure: participants
Non-responder	5	6
Responder	3	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	pEGFR<=20 μg/ml, pEGFR>20 μg/ml
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.000
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

8.Secondary Outcome


Title	Response by EGFR Mutation Status
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Radiologic evaluation every 3 months, up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	No EGFR Mutation	EGFR Mutation
Arm/Group Description:	Assessed by fluorescent in situ hyb...	Assessed by fluorescent in situ hyb...
Arm/Group Description:	Assessed by fluorescent in situ hybridization (FISH)	Assessed by fluorescent in situ hybridization (FISH)
Overall Number of Participants Analyzed	12	4
Measure Type: Number Unit of Measure: participants
Nonresponder	9	2
Responder	3	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No EGFR Mutation, EGFR Mutation
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5467
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Erlotinib in Combination With Radiotherapy
Arm/Group Description	Erlotinib (150 mg) administered ora...
Arm/Group Description	Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
All-Cause Mortality
	Erlotinib in Combination With Radiotherapy
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Erlotinib in Combination With Radiotherapy
	Affected / at Risk (%)	# Events
Total	9/17 (52.94%)
Cardiac disorders
Cardiac failure congestive - Grade 5 ^†	1/17 (5.88%)	1
Myocardial infarction - Grade 4 ^†	1/17 (5.88%)	1
Gastrointestinal disorders
Diarrhoea - Grade 3 ^†	3/17 (17.65%)	5
Ileus - Grade 3 ^†	2/17 (11.76%)	2
Oesophageal stenosis - Grade 2 ^†	1/17 (5.88%)	1
General disorders
Death - Grade 5 ^†	2/17 (11.76%)	2
Fatigue - Grade 3 ^†	1/17 (5.88%)	1
Non-cardiac chest pain - Grade 3 ^†	1/17 (5.88%)	1
Infections and infestations
Pneumonia - Grade 3 ^†	1/17 (5.88%)	1
Investigations
Haemoglobin - Grade 2 ^†	1/17 (5.88%)	1
Metabolism and nutrition disorders
Dehydration - Grade 3 ^†	3/17 (17.65%)	4
Hyperglycaemia - Grade 2 ^†	1/17 (5.88%)	1
Hypoalbuminaemia - Grade 2 ^†	1/17 (5.88%)	1
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 3 ^†	1/17 (5.88%)	1
Nervous system disorders
Nervous system disorder - Grade 4 ^†	1/17 (5.88%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 4 ^†	1/17 (5.88%)	1
Respiratory distress - Grade 3 ^†	1/17 (5.88%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Erlotinib in Combination With Radiotherapy
	Affected / at Risk (%)	# Events
Total	17/17 (100.00%)
Blood and lymphatic system disorders
Anaemia - Grade 1 ^†	1/17 (5.88%)	2
Anaemia - Grade 2 ^†	2/17 (11.76%)	2
Leukopenia - Grade 1 ^†	3/17 (17.65%)	4
Leukopenia - Grade 2 ^†	1/17 (5.88%)	1
Lymphopenia - Grade 1 ^†	7/17 (41.18%)	10
Lymphopenia - Grade 2 ^†	11/17 (64.71%)	17
Lymphopenia - Grade 3 ^†	8/17 (47.06%)	10
Lymphopenia - Grade 4 ^†	2/17 (11.76%)	2
Neutropenia - Grade 1 ^†	1/17 (5.88%)	2
Neutropenia - Grade 2 ^†	1/17 (5.88%)	1
Thrombocytopenia - Grade 1 ^†	2/17 (11.76%)	2
Cardiac disorders
Acute myocardial infarction - Grade 4 ^†	1/17 (5.88%)	1
Angina pectoris - Grade 1 ^†	1/17 (5.88%)	1
Angina pectoris - Grade 2 ^†	1/17 (5.88%)	2
Ventricular arrhythmia - Grade 4 ^†	1/17 (5.88%)	1
Eye disorders
Vision blurred - Grade 3 ^†	1/17 (5.88%)	1
Gastrointestinal disorders
Abdominal distension - Grade 1 ^†	1/17 (5.88%)	1
Abdominal pain - Grade 1 ^†	3/17 (17.65%)	3
Chapped lips - Grade 1 ^†	1/17 (5.88%)	1
Constipation - Grade 1 ^†	2/17 (11.76%)	2
Constipation - Grade 2 ^†	1/17 (5.88%)	2
Diarrhoea - Grade 1 ^†	8/17 (47.06%)	16
Diarrhoea - Grade 2 ^†	3/17 (17.65%)	3
Dyspepsia - Grade 1 ^†	1/17 (5.88%)	1
Dyspepsia - Grade 2 ^†	1/17 (5.88%)	1
Dysphagia - Grade 1 ^†	2/17 (11.76%)	2
Dysphagia - Grade 2 ^†	5/17 (29.41%)	5
Dysphagia - Grade 3 ^†	2/17 (11.76%)	2
Eructation - Grade 1 ^†	1/17 (5.88%)	1
Flatulence - Grade 1 ^†	1/17 (5.88%)	1
Gastritis - Grade 1 ^†	1/17 (5.88%)	1
Gastrooesophageal reflux disease - Grade 1 ^†	1/17 (5.88%)	1
Impaired gastric emptying - Grade 2 ^†	1/17 (5.88%)	1
Nausea - Grade 1 ^†	6/17 (35.29%)	10
Nausea - Grade 2 ^†	1/17 (5.88%)	1
Nausea - Grade 3 ^†	1/17 (5.88%)	1
Odynophagia - Grade 1 ^†	1/17 (5.88%)	1
Odynophagia - Grade 2 ^†	1/17 (5.88%)	1
Oesophageal obstruction - Grade 3 ^†	1/17 (5.88%)	1
Oesophageal stenosis - Grade 2 ^†	2/17 (11.76%)	2
Oesophageal stenosis - Grade 3 ^†	1/17 (5.88%)	1
Oesophagitis - Grade 1 ^†	1/17 (5.88%)	1
Oesophagitis - Grade 2 ^†	2/17 (11.76%)	2
Reflux oesophagitis - Grade 1 ^†	1/17 (5.88%)	1
Reflux oesophagitis - Grade 2 ^†	2/17 (11.76%)	2
Retching - Grade 1 ^†	1/17 (5.88%)	1
Stomatitis - Grade 1 ^†	2/17 (11.76%)	2
Stomatitis - Grade 2 ^†	2/17 (11.76%)	2
Vomiting - Grade 1 ^†	4/17 (23.53%)	8
Vomiting - Grade 2 ^†	3/17 (17.65%)	3
General disorders
Chills - Grade 1 ^†	1/17 (5.88%)	1
Early satiety - Grade 2 ^†	1/17 (5.88%)	1
Fatigue - Grade 1 ^†	11/17 (64.71%)	14
Fatigue - Grade 2 ^†	12/17 (70.59%)	12
Fatigue - Grade 3 ^†	1/17 (5.88%)	1
Mucosal inflammation - Grade 1 ^†	4/17 (23.53%)	6
Oedema - Grade 1 ^†	1/17 (5.88%)	1
Oedema peripheral - Grade 1 ^†	3/17 (17.65%)	3
Oedema peripheral - Grade 2 ^†	1/17 (5.88%)	1
Pain - Grade 2 ^†	3/17 (17.65%)	3
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 1 ^†	2/17 (11.76%)	4
Hyperbilirubinaemia - Grade 2 ^†	1/17 (5.88%)	1
Infections and infestations
Fungal skin infection - Grade 1 ^†	1/17 (5.88%)	1
Fungal skin infection - Grade 2 ^†	1/17 (5.88%)	2
Infection - Grade 2 ^†	1/17 (5.88%)	2
Urinary tract infection - Grade 2 ^†	2/17 (11.76%)	2
Injury, poisoning and procedural complications
Contusion - Grade 1 ^†	1/17 (5.88%)	1
Facial bones fracture - Grade 2 ^†	1/17 (5.88%)	1
Procedural site reaction - Grade 2 ^†	1/17 (5.88%)	1
Rib fracture - Grade 2 ^†	1/17 (5.88%)	1
Skin laceration - Grade 2 ^†	1/17 (5.88%)	1
Investigations
Alanine aminotransferase increased - Grade 1 ^†	3/17 (17.65%)	3
Aspartate aminotransferase - Grade 1 ^†	2/17 (11.76%)	2
Aspartate aminotransferase increased - Grade 1 ^†	5/17 (29.41%)	7
Aspartate aminotransferase increased - Grade 2 ^†	1/17 (5.88%)	1
Blood alkaline phosphatase - Grade 1 ^†	2/17 (11.76%)	3
Blood alkaline phosphatase - Grade 2 ^†	1/17 (5.88%)	1
Blood alkaline phosphatase increased - Grade 1 ^†	1/17 (5.88%)	1
Blood bilirubin - Grade 1 ^†	2/17 (11.76%)	2
Blood bilirubin - Grade 2 ^†	2/17 (11.76%)	2
Blood bilirubin increased - Grade 1 ^†	1/17 (5.88%)	1
Blood bilirubin increased - Grade 2 ^†	1/17 (5.88%)	2
Blood calcium decreased - Grade 1 ^†	1/17 (5.88%)	1
Blood creatine - Grade 2 ^†	1/17 (5.88%)	1
Blood creatine increased - Grade 1 ^†	1/17 (5.88%)	1
Blood creatinine - Grade 1 ^†	3/17 (17.65%)	3
Blood creatinine - Grade 2 ^†	1/17 (5.88%)	5
Haemoglobin - Grade 1 ^†	6/17 (35.29%)	7
International normalised ratio increased - Grade 1 ^†	1/17 (5.88%)	1
International normalised ratio increased - Grade 2 ^†	1/17 (5.88%)	1
International normalised ratio increased - Grade 3 ^†	1/17 (5.88%)	2
Platelet count decreased - Grade 1 ^†	4/17 (23.53%)	6
Troponin I increased - Grade 4 ^†	1/17 (5.88%)	1
Weight decreased - Grade 1 ^†	10/17 (58.82%)	11
Weight decreased - Grade 2 ^†	5/17 (29.41%)	5
Metabolism and nutrition disorders
Anorexia - Grade 1 ^†	4/17 (23.53%)	6
Anorexia - Grade 2 ^†	5/17 (29.41%)	6
Anorexia - Grade 3 ^†	1/17 (5.88%)	1
Dehydration - Grade 1 ^†	1/17 (5.88%)	1
Dehydration - Grade 2 ^†	5/17 (29.41%)	6
Gout - Grade 2 ^†	1/17 (5.88%)	1
Hypercalcaemia - Grade 1 ^†	1/17 (5.88%)	2
Hyperglycaemia - Grade 1 ^†	4/17 (23.53%)	7
Hyperglycaemia - Grade 2 ^†	4/17 (23.53%)	5
Hyperkalaemia - Grade 1 ^†	3/17 (17.65%)	4
Hypernatraemia - Grade 1 ^†	1/17 (5.88%)	1
Hypoalbuminaemia - Grade 1 ^†	5/17 (29.41%)	5
Hypoalbuminaemia - Grade 2 ^†	4/17 (23.53%)	6
Hypocalcaemia - Grade 1 ^†	2/17 (11.76%)	4
Hypocalcaemia - Grade 2 ^†	1/17 (5.88%)	1
Hypoglycaemia - Grade 1 ^†	1/17 (5.88%)	1
Hypokalaemia - Grade 1 ^†	2/17 (11.76%)	2
Hypomagnesaemia - Grade 1 ^†	1/17 (5.88%)	1
Hyponatraemia - Grade 1 ^†	6/17 (35.29%)	8
Hyponatraemia - Grade 3 ^†	1/17 (5.88%)	1
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 1 ^†	1/17 (5.88%)	2
Back pain - Grade 1 ^†	3/17 (17.65%)	3
Buttock pain - Grade 1 ^†	1/17 (5.88%)	1
Gouty arthritis - Grade 1 ^†	1/17 (5.88%)	1
Groin pain - Grade 1 ^†	2/17 (11.76%)	2
Groin pain - Grade 2 ^†	1/17 (5.88%)	1
Muscle spasms - Grade 1 ^†	1/17 (5.88%)	1
Musculoskeletal chest pain - Grade 1 ^†	1/17 (5.88%)	1
Musculoskeletal chest pain - Grade 2 ^†	1/17 (5.88%)	1
Musculoskeletal pain - Grade 2 ^†	2/17 (11.76%)	2
Pain in extremity - Grade 1 ^†	1/17 (5.88%)	1
Pain in extremity - Grade 2 ^†	2/17 (11.76%)	2
Nervous system disorders
Dizziness - Grade 1 ^†	1/17 (5.88%)	3
Dizziness - Grade 2 ^†	1/17 (5.88%)	1
Dysgeusia - Grade 1 ^†	4/17 (23.53%)	5
Headache - Grade 1 ^†	1/17 (5.88%)	1
Syncope - Grade 3 ^†	2/17 (11.76%)	2
Tremor - Grade 1 ^†	1/17 (5.88%)	1
Psychiatric disorders
Depression - Grade 1 ^†	1/17 (5.88%)	1
Depression - Grade 2 ^†	2/17 (11.76%)	2
Insomnia - Grade 1 ^†	1/17 (5.88%)	1
Insomnia - Grade 2 ^†	2/17 (11.76%)	2
Renal and urinary disorders
Pollakiuria - Grade 2 ^†	1/17 (5.88%)	1
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1 ^†	4/17 (23.53%)	5
Dysphonia - Grade 1 ^†	2/17 (11.76%)	2
Dysphonia - Grade 2 ^†	1/17 (5.88%)	1
Dyspnoea - Grade 1 ^†	2/17 (11.76%)	2
Dyspnoea - Grade 3 ^†	2/17 (11.76%)	2
Epistaxis - Grade 1 ^†	1/17 (5.88%)	1
Epistaxis - Grade 2 ^†	1/17 (5.88%)	1
Hiccups - Grade 1 ^†	1/17 (5.88%)	1
Skin and subcutaneous tissue disorders
Decubitus ulcer - Grade 2 ^†	1/17 (5.88%)	1
Dermatitis acneiform - Grade 1 ^†	1/17 (5.88%)	1
Dermatitis acneiform - Grade 2 ^†	1/17 (5.88%)	1
Drug eruption - Grade 1 ^†	3/17 (17.65%)	3
Drug eruption - Grade 2 ^†	3/17 (17.65%)	4
Hyperhidrosis - Grade 2 ^†	1/17 (5.88%)	1
Palmar-plantar erythrodysaesthesia syndrome - Grade 1 ^†	2/17 (11.76%)	4
Palmar-plantar erythrodysaesthesia syndrome - Grade 2 ^†	2/17 (11.76%)	2
Pruritus - Grade 1 ^†	1/17 (5.88%)	1
Pruritus - Grade 2 ^†	1/17 (5.88%)	1
Rash - Grade 1 ^†	6/17 (35.29%)	14
Rash - Grade 2 ^†	7/17 (41.18%)	8
Rash pruritic - Grade 2 ^†	1/17 (5.88%)	1
Skin disorder - Grade 2 ^†	1/17 (5.88%)	1
Skin exfoliation - Grade 1 ^†	1/17 (5.88%)	1
Skin ulcer - Grade 1 ^†	1/17 (5.88%)	1
Vascular disorders
Deep vein thrombosis - Grade 3 ^†	1/17 (5.88%)	1
Hypotension - Grade 2 ^†	1/17 (5.88%)	1
Hypotension - Grade 4 ^†	1/17 (5.88%)	1
Orthostatic hypotension - Grade 1 ^†	1/17 (5.88%)	2
Orthostatic hypotension - Grade 2 ^†	1/17 (5.88%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Senior Administrator, Compliance - Clinical Research Services
Organization:	Roswell Park Cancer Institute
Phone:	716-845-2300

Layout table for additonal information

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00524121
Other Study ID Numbers:	CDR0000563268 RPCI-I-62705 ( Other Identifier: Roswell Park Cancer Institute )
First Submitted:	August 31, 2007
First Posted:	September 3, 2007
Results First Submitted:	August 23, 2013
Results First Posted:	March 5, 2015
Last Update Posted:	April 14, 2016

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