Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01178944
Collaborator
National Cancer Institute (NCI) (NIH), National Comprehensive Cancer Network (Other)
35
2
1
62
17.5
0.3

Study Details

Study Description

Brief Summary

This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the overall response rate in patients with advanced esophago-gastric cancer (EGC) to combination pralatrexate and oxaliplatin.
SECONDARY OBJECTIVES:
  1. To examine the toxicity and tolerability of this regimen. II. To determine the time-to-progression and overall survival using this regimen.

  2. To examine whether functionally relevant polymorphisms of genes of the folate metabolism pathway correlate with efficacy and toxicity of pralatrexate.

  3. To examine whether response to pralatrexate can be predicted by micro-ribonucleic acid (microRNA) expression profiling of the epithelial component of the tumor.

OUTLINE:

Patients receive pralatrexate intravenously (IV) over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.

After completion of study treatment, patients are followed up for 30 days and then periodically thereafter for up to 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pralatrexate in Combination With Oxaliplatin in Advanced Esophago-gastric Cancer: A Phase II Trial With Predictive Molecular Correlates
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (pralatrexate, oxaliplatin)

Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatin
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669
  • Drug: Pralatrexate
    Given IV
    Other Names:
  • 10-propargyl-10-deazaaminopterin
  • Folotyn
  • PDX
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [Up to 5 years]

      Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Secondary Outcome Measures

    1. Number of Participants With an Adverse Event [Up to 30 days after the last dose of study drug(s)]

      Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    2. Overall Survival (OS) [From the date of study enrollment to the time of death from any cause, assessed up to 5 years]

      Estimated using the Kaplan-Meier method and proportional hazards models.

    3. Time to Progression (TTP) [From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years]

      Estimated using the Kaplan-Meier method and proportional hazards models.

    Other Outcome Measures

    1. Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes [From the date of study enrollment up to 5 years]

      Kaplan-Meier estimates of median survival time for each genotype

    2. MicroRNA Expression - miR-215-5p [Baseline]

      Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed carcinoma of the esophagus, stomach or gastro-esophageal junction that is metastatic, or locally advanced and inoperable for cure; histological sub-types permitted include adenocarcinoma, squamous-cell carcinoma, or undifferentiated carcinoma; small-cell carcinoma variant is not eligible

    • No previous systemic therapy for metastatic or recurrent disease; therapy (chemotherapy, radiotherapy, or both) administered in the neo-adjuvant, adjuvant, or definitive setting for previously localized disease is permitted, provided it was completed more than 6 months prior to enrollment; palliative radiotherapy is permitted provided it is completed >= 3 weeks prior to study therapy initiation

    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    • Life expectancy >= 12 weeks

    • Hemoglobin >= 9 g/dl

    • Absolute neutrophil count >= 1500/mm^3

    • Platelet count >= 100,000/mm^3

    • Serum creatinine =< institutional upper limit normal (ULN)

    • Bilirubin =< 1.5 x ULN

    • Transaminases =< 3 x ULN; for documented liver metastases, transaminases up to 5 x ULN is permitted

    • No evidence of >= grade 2 peripheral neuropathy

    • Patients with reproductive potential must be willing to use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment; a negative pregnancy test is required for women of child-bearing potential; nursing women are ineligible

    • Written, informed consent

    Exclusion Criteria:
    • Hypersensitivity to platinum compounds

    • Uncontrolled inter-current illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements

    • Presence of brain metastases

    • Patients with third-space (pleural, peritoneal) fluid not controllable with usual drainage methods are not eligible

    • History of second primary malignancy within 3 years prior to enrollment, except for in-situ cervix carcinoma or non-melanoma skin cancer

    • Undergone an allogeneic stem cell transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263
    2 Rochester General Hospital Rochester New York United States 14621

    Sponsors and Collaborators

    • Roswell Park Cancer Institute
    • National Cancer Institute (NCI)
    • National Comprehensive Cancer Network

    Investigators

    • Principal Investigator: Nikhil Khushalani, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01178944
    Other Study ID Numbers:
    • I 169210
    • NCI-2010-01583
    • I 169210
    • P30CA016056
    First Posted:
    Aug 10, 2010
    Last Update Posted:
    Dec 13, 2017
    Last Verified:
    Nov 1, 2017

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Period Title: Overall Study
    STARTED 35
    COMPLETED 35
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Overall Participants 35
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.7
    (9.9)
    Sex: Female, Male (Count of Participants)
    Female
    3
    8.6%
    Male
    32
    91.4%

    Outcome Measures

    1. Primary Outcome
    Title Overall Response Rate
    Description Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    All Cohort -1 treated and eligible patients
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Measure Participants 31
    Number (95% Confidence Interval) [percentage of participants]
    26
    74.3%
    2. Secondary Outcome
    Title Number of Participants With an Adverse Event
    Description Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
    Time Frame Up to 30 days after the last dose of study drug(s)

    Outcome Measure Data

    Analysis Population Description
    All treated and eligible patients
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Measure Participants 35
    Number [participants]
    35
    100%
    3. Secondary Outcome
    Title Overall Survival (OS)
    Description Estimated using the Kaplan-Meier method and proportional hazards models.
    Time Frame From the date of study enrollment to the time of death from any cause, assessed up to 5 years

    Outcome Measure Data

    Analysis Population Description
    All treated and eligible patients.
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Measure Participants 35
    Median (95% Confidence Interval) [months]
    7.2
    4. Secondary Outcome
    Title Time to Progression (TTP)
    Description Estimated using the Kaplan-Meier method and proportional hazards models.
    Time Frame From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years

    Outcome Measure Data

    Analysis Population Description
    All treated and eligible patients
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Measure Participants 35
    Median (95% Confidence Interval) [months]
    5.1
    5. Other Pre-specified Outcome
    Title Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes
    Description Kaplan-Meier estimates of median survival time for each genotype
    Time Frame From the date of study enrollment up to 5 years

    Outcome Measure Data

    Analysis Population Description
    All treated and eligible patients
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Measure Participants 35
    C
    10.22
    T
    18.71
    TC
    4.63
    6. Other Pre-specified Outcome
    Title MicroRNA Expression - miR-215-5p
    Description Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    All treated participants that had enough tissue to perform microdissection to collect epithelial cells for subsequent microRNA profiling.
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    Measure Participants 29
    Responders: CR+PR
    6.6
    Non responders: stable disease/progression
    5.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment (Pralatrexate, Oxaliplatin)
    Comments Comparison is CR+PR vs stable disease/progression
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.585
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    0.78 to 1.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
    Arm/Group Description Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses. Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Pralatrexate: Given IV
    All Cause Mortality
    Treatment (Pralatrexate, Oxaliplatin)
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Treatment (Pralatrexate, Oxaliplatin)
    Affected / at Risk (%) # Events
    Total 10/35 (28.6%)
    Cardiac disorders
    Myocardial infarction 1/35 (2.9%) 2
    Gastrointestinal disorders
    Gastric haemorrhage 1/35 (2.9%) 2
    Stomatitis 1/35 (2.9%) 2
    General disorders
    Disease progression 1/35 (2.9%) 2
    Pyrexia 1/35 (2.9%) 2
    Infections and infestations
    Infection 1/35 (2.9%) 4
    Lung infection 1/35 (2.9%) 2
    Urinary tract infection 1/35 (2.9%) 2
    Investigations
    Haemoglobin 1/35 (2.9%) 4
    Metabolism and nutrition disorders
    Dehydration 3/35 (8.6%) 6
    Hypokalaemia 1/35 (2.9%) 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm 1/35 (2.9%) 2
    Neoplasm malignant 1/35 (2.9%) 2
    Nervous system disorders
    Haemorrhage intracranial 1/35 (2.9%) 2
    Respiratory, thoracic and mediastinal disorders
    Aspiration 1/35 (2.9%) 2
    Dyspnoea 1/35 (2.9%) 2
    Pleural effusion 1/35 (2.9%) 2
    Other (Not Including Serious) Adverse Events
    Treatment (Pralatrexate, Oxaliplatin)
    Affected / at Risk (%) # Events
    Total 35/35 (100%)
    Blood and lymphatic system disorders
    Anaemia 9/35 (25.7%) 37
    Leukopenia 12/35 (34.3%) 65
    Lymphopenia 12/35 (34.3%) 32
    Neutropenia 12/35 (34.3%) 42
    Thrombocytopenia 10/35 (28.6%) 50
    Cardiac disorders
    Tachycardia 3/35 (8.6%) 6
    Eye disorders
    Dry eye 1/35 (2.9%) 4
    Eye discharge 2/35 (5.7%) 4
    Eye pain 1/35 (2.9%) 2
    Lacrimation increased 1/35 (2.9%) 2
    Vision blurred 2/35 (5.7%) 6
    Gastrointestinal disorders
    Abdominal pain 7/35 (20%) 16
    Abdominal pain lower 1/35 (2.9%) 1
    Abdominal pain upper 3/35 (8.6%) 6
    Ascites 1/35 (2.9%) 4
    Constipation 13/35 (37.1%) 42
    Diarrhoea 14/35 (40%) 71
    Dry mouth 3/35 (8.6%) 6
    Dyspepsia 1/35 (2.9%) 2
    Dysphagia 6/35 (17.1%) 20
    Faecal incontinence 1/35 (2.9%) 2
    Flatulence 1/35 (2.9%) 2
    Gastrooesophageal reflux disease 1/35 (2.9%) 2
    Impaired gastric emptying 1/35 (2.9%) 2
    Mouth haemorrhage 1/35 (2.9%) 2
    Nausea 22/35 (62.9%) 96
    Odynophagia 1/35 (2.9%) 2
    Oesophageal stenosis 1/35 (2.9%) 2
    Oesophagitis 1/35 (2.9%) 2
    Stomatitis 30/35 (85.7%) 169
    Vomiting 17/35 (48.6%) 55
    General disorders
    Asthenia 1/35 (2.9%) 2
    Chest pain 4/35 (11.4%) 8
    Chills 1/35 (2.9%) 2
    Early satiety 1/35 (2.9%) 2
    Fatigue 23/35 (65.7%) 103
    Gait disturbance 1/35 (2.9%) 2
    Infusion site extravasation 1/35 (2.9%) 2
    Localised oedema 1/35 (2.9%) 2
    Oedema 1/35 (2.9%) 2
    Oedema peripheral 8/35 (22.9%) 25
    Pain 1/35 (2.9%) 2
    Pyrexia 3/35 (8.6%) 6
    Temperature intolerance 3/35 (8.6%) 10
    Hepatobiliary disorders
    Hyperbilirubinaemia 2/35 (5.7%) 8
    Immune system disorders
    Hypersensitivity 3/35 (8.6%) 6
    Infections and infestations
    Abdominal wall infection 1/35 (2.9%) 2
    Infection 1/35 (2.9%) 4
    Nasopharyngitis 1/35 (2.9%) 2
    Oral candidiasis 2/35 (5.7%) 4
    Oral infection 1/35 (2.9%) 2
    Pneumonia 1/35 (2.9%) 2
    Skin infection 1/35 (2.9%) 4
    Upper respiratory tract infection 1/35 (2.9%) 2
    Injury, poisoning and procedural complications
    Contusion 1/35 (2.9%) 2
    Feeding tube complication 1/35 (2.9%) 2
    Infusion related reaction 1/35 (2.9%) 2
    Road traffic accident 1/35 (2.9%) 2
    Thermal burn 1/35 (2.9%) 2
    Wound dehiscence 1/35 (2.9%) 2
    Investigations
    Alanine aminotransferase increased 2/35 (5.7%) 10
    Aspartate aminotransferase 5/35 (14.3%) 16
    Aspartate aminotransferase increased 12/35 (34.3%) 40
    Blood alkaline phosphatase 6/35 (17.1%) 15
    Blood alkaline phosphatase increased 9/35 (25.7%) 27
    Blood creatinine 4/35 (11.4%) 10
    Blood creatinine increased 2/35 (5.7%) 3
    Carbon dioxide increased 1/35 (2.9%) 2
    Haemoglobin 12/35 (34.3%) 75
    Haemoglobin decreased 9/35 (25.7%) 47
    Lymphocyte count decreased 9/35 (25.7%) 49
    Neutrophil count decreased 5/35 (14.3%) 13
    Platelet count decreased 5/35 (14.3%) 21
    Weight decreased 14/35 (40%) 42
    White blood cell count decreased 6/35 (17.1%) 18
    Metabolism and nutrition disorders
    Decreased appetite 9/35 (25.7%) 25
    Dehydration 8/35 (22.9%) 16
    Hypercalcaemia 2/35 (5.7%) 4
    Hyperglycaemia 1/35 (2.9%) 2
    Hyperkalaemia 7/35 (20%) 21
    Hypernatraemia 4/35 (11.4%) 8
    Hypoalbuminaemia 18/35 (51.4%) 69
    Hypocalcaemia 3/35 (8.6%) 6
    Hypoglycaemia 1/35 (2.9%) 2
    Hypokalaemia 4/35 (11.4%) 8
    Hypomagnesaemia 1/35 (2.9%) 2
    Hyponatraemia 8/35 (22.9%) 27
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/35 (2.9%) 6
    Back pain 5/35 (14.3%) 10
    Flank pain 1/35 (2.9%) 2
    Joint effusion 1/35 (2.9%) 2
    Muscular weakness 5/35 (14.3%) 9
    Musculoskeletal pain 1/35 (2.9%) 2
    Myalgia 1/35 (2.9%) 4
    Neck pain 2/35 (5.7%) 6
    Pain in extremity 4/35 (11.4%) 8
    Pain in jaw 1/35 (2.9%) 2
    Nervous system disorders
    Dizziness 6/35 (17.1%) 16
    Dizziness postural 1/35 (2.9%) 2
    Dysaesthesia 2/35 (5.7%) 4
    Dysgeusia 11/35 (31.4%) 24
    Headache 6/35 (17.1%) 11
    Neuropathy peripheral 1/35 (2.9%) 2
    Paraesthesia 4/35 (11.4%) 22
    Peripheral sensory neuropathy 27/35 (77.1%) 106
    Peroneal nerve palsy 1/35 (2.9%) 4
    Sinus headache 1/35 (2.9%) 2
    Psychiatric disorders
    Anxiety 2/35 (5.7%) 6
    Confusional state 1/35 (2.9%) 2
    Delirium 1/35 (2.9%) 2
    Hallucination 1/35 (2.9%) 2
    Insomnia 1/35 (2.9%) 4
    Restlessness 1/35 (2.9%) 2
    Renal and urinary disorders
    Chromaturia 1/35 (2.9%) 2
    Dysuria 1/35 (2.9%) 2
    Haematuria 1/35 (2.9%) 2
    Nephrolithiasis 1/35 (2.9%) 2
    Pollakiuria 2/35 (5.7%) 3
    Urinary incontinence 1/35 (2.9%) 2
    Respiratory, thoracic and mediastinal disorders
    Cough 4/35 (11.4%) 10
    Dysphonia 5/35 (14.3%) 14
    Dyspnoea 4/35 (11.4%) 8
    Dyspnoea exertional 1/35 (2.9%) 2
    Epistaxis 12/35 (34.3%) 24
    Hiccups 3/35 (8.6%) 6
    Hypoxia 1/35 (2.9%) 2
    Nasal congestion 2/35 (5.7%) 4
    Oropharyngeal pain 1/35 (2.9%) 2
    Pleural effusion 1/35 (2.9%) 4
    Wheezing 2/35 (5.7%) 4
    Skin and subcutaneous tissue disorders
    Alopecia 2/35 (5.7%) 4
    Decubitus ulcer 1/35 (2.9%) 2
    Dry skin 2/35 (5.7%) 6
    Hyperhidrosis 1/35 (2.9%) 2
    Night sweats 1/35 (2.9%) 2
    Rash 6/35 (17.1%) 12
    Rash papular 1/35 (2.9%) 2
    Skin hyperpigmentation 1/35 (2.9%) 2
    Skin ulcer 1/35 (2.9%) 2
    Surgical and medical procedures
    Medical diet 1/35 (2.9%) 2
    Vascular disorders
    Deep vein thrombosis 5/35 (14.3%) 10
    Embolism 1/35 (2.9%) 2
    Hot flush 1/35 (2.9%) 2
    Hypertension 1/35 (2.9%) 2
    Hypotension 5/35 (14.3%) 10
    Orthostatic hypotension 1/35 (2.9%) 2
    Superior vena cava syndrome 1/35 (2.9%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Senior Administrator, Compliance - Clinical Research Services
    Organization Roswell Park Cancer Institute
    Phone 716-845-2300
    Email
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01178944
    Other Study ID Numbers:
    • I 169210
    • NCI-2010-01583
    • I 169210
    • P30CA016056
    First Posted:
    Aug 10, 2010
    Last Update Posted:
    Dec 13, 2017
    Last Verified:
    Nov 1, 2017