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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib in Combination With Radiotherapy
Hide 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
Arm/Group Title Erlotinib in Combination With Radiotherapy
Hide 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
Hide 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%
1.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib in Combination With Radiotherapy
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients Treated with Study Therapy
Arm/Group Title Erlotinib in Combination With Radiotherapy
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib in Combination With Radiotherapy
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients Treated with Study Therapy
Arm/Group Title Current Smokers Former Smokers Never Smokers
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Radiologic evaluation every 3 months, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EGFR<=120 μg/ml EGFR>120 μg/ml
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Radiologic evaluation every 3 months, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title pEGFR<=20 μg/ml pEGFR>20 μg/ml
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Radiologic evaluation every 3 months, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No EGFR Mutation EGFR Mutation
Hide 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
Hide 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]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib in Combination With Radiotherapy
Hide 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   --/--    
Hide 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
Hide 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
[Not Specified]
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