Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
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:
- To determine the overall response rate in patients with advanced esophago-gastric cancer (EGC) to combination pralatrexate and oxaliplatin.
SECONDARY OBJECTIVES:
-
To examine the toxicity and tolerability of this regimen. II. To determine the time-to-progression and overall survival using this regimen.
-
To examine whether functionally relevant polymorphisms of genes of the folate metabolism pathway correlate with efficacy and toxicity of pralatrexate.
-
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
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:
Drug: Pralatrexate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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.
- 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
- 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
- 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
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.- I 169210
- NCI-2010-01583
- I 169210
- P30CA016056
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
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%
|
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%
|
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
|
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
|
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
|
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
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 |
- I 169210
- NCI-2010-01583
- I 169210
- P30CA016056