S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00109928
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 34
• Locations: 77
• Arm: 1
• Duration (Months): 103
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: cisplatin; Drug: etoposide; Drug: gemcitabine; Drug: methylprednisolone	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine 2-year overall survival of patients with newly diagnosed, bulky stage II or stage III or IV peripheral T-cell non-Hodgkin's lymphoma treated with cisplatin, etoposide, gemcitabine, and methylprednisolone.

Secondary

• Determine the toxicity of this regimen in these patients.

• Determine the response rate (complete unconfirmed response, complete response, and partial response) in patients treated with this regimen.

• Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients receive cisplatin IV over 30-60 minutes, etoposide IV over 30-60 minutes, and methylprednisolone IV over 5 minutes on days 1-4. Patients also receive gemcitabine IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-6 weeks, 3 months, and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEGS Treatment VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1	Drug: cisplatin; Drug: etoposide; Drug: gemcitabine; Drug: methylprednisolone

Outcome Measures

Primary Outcome Measures

1. 2-year Overall Survival Rate [0-2 years]

   The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.

Secondary Outcome Measures

1. 2-year Progression-free Survival Rate [0-2 years]

   Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.

2. Response Rate [up to 3 years or time of disease progression]

   Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

3. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [up to 18 weeks of protocol treatment]

   Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of peripheral T-cell non-Hodgkin's lymphoma

• Newly diagnosed, relapsed or progressing disease after 1 prior treatment with a non-platinum based chemotherapy (e.g., CHOP)

• Bulky stage II or stage III or IV disease

• The following histologies are not eligible:

• T-cell prolymphocytic leukemia

• T-cell large granular lymphocytic leukemia

• Any NK-cell leukemia

• Adult T-cell leukemia/lymphoma

• Mycosis fungoides/Sézary syndrome

• Lymphomatoid papulosis

• Nasal-type extranodal NK/T-cell lymphoma

• Enteropathy-type T-cell lymphoma

• Hepatosplenic T-cell lymphoma

• Subcutaneous panniculitis-like T-cell lymphoma

• Angioimmunoblastic T-cell lymphoma

• Primary cutaneous anaplastic large cell lymphoma (ALCL)

• ALCL with CD30, ALK, and EMA expression

• ALCL morphology that fails to express ALK or EMA allowed provided T-cell lineage is confirmed by immunotyping or genetic testing

• Bidimensionally measurable disease

• Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the original diagnostic specimen available

• Needle aspiration or cytology is not considered adequate samples

• No clinical evidence of Central nervous system (CNS) involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2 times upper limit of normal

Renal

• Creatinine clearance ≥ 30 mL/min

Cardiovascular

• No history of congestive heart failure

• No history of myocardial infarction

• No history of unstable angina

• No history of asymptomatic arrhythmias

• Ejection fraction normal by multigated acquisition (MUGA) scan (for patients with questionable cardiac history)

• No other history of impaired cardiac status

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known HIV positivity

• Mild clinical hearing loss allowed provided patient is willing to accept the potential for worsening of hearing loss

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and pelvis within the past 28 days

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 weeks since prior biologic therapy

• No concurrent routine use of bone marrow colony-stimulating factors

Chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for this cancer

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No prior cytotoxic therapy for this cancer

• Concurrent enrollment in SWOG-8819 or SWOG-8947 allowed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724-5024
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Kaiser Permanente - Fremont	Fremont	California	United States	94538
4	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
5	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
6	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
7	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
8	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
9	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
10	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
11	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
12	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
13	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
14	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
15	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
16	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
17	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
18	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
19	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
20	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
21	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
22	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
23	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
24	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
25	Highland Clinic	Shreveport	Louisiana	United States	71105
26	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
27	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
28	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
29	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
30	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
31	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
32	Hurley Medical Center	Flint	Michigan	United States	48503
33	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
34	Foote Memorial Hospital	Jackson	Michigan	United States	49201
35	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
36	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
37	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
38	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
39	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
40	St. John Macomb Hospital	Warren	Michigan	United States	48093
41	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
42	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
43	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
44	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
45	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
46	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
47	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
48	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
49	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
50		Great Falls	Montana	United States	59405
51	Northern Montana Hospital	Havre	Montana	United States	59501
52	St. Peter's Hospital	Helena	Montana	United States	59601
53	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
54	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
55	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
56	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
57	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
58	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
59	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
60	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
61	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
62	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
63	Columbia Basin Hematology	Kennewick	Washington	United States	99336
64	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington	United States	98273
65	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
66	Harborview Medical Center	Seattle	Washington	United States	98104
67	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
68	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
69	Group Health Central Hospital	Seattle	Washington	United States	98112
70	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
71	Polyclinic First Hill	Seattle	Washington	United States	98122
72	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
73	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
74	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
75	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
76	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
77	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Daruka Mahadevan, MD, PhD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00109928
• Other Study ID Numbers: CDR0000425643; S0350; U10CA032102
• First Posted: May 4, 2005
• Last Update Posted: Oct 1, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Southwest Oncology Group: stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; anaplastic large cell lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Gemcitabine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Etoposide; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
Period Title: Overall Study
STARTED	34
Eligible	33
Eligible and Began Protocol Therapy	33
COMPLETED	21
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
Overall Participants	33
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	11 33.3%
Male	22 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.1%
Not Hispanic or Latino	31 93.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 12.1%
White	28 84.8%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	2-year Overall Survival Rate
Description	The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
Time Frame	0-2 years

Outcome Measure Data

Analysis Population Description

All eligible patients who started protocol treatment were included in the analysis

Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
Measure Participants	33
Number (95% Confidence Interval) [percentage of participants]	31 93.9%

2. Secondary Outcome

Title	2-year Progression-free Survival Rate
Description	Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.
Time Frame	0-2 years

Outcome Measure Data

Analysis Population Description

All eligible patients who started protocol treatment were included in the analysis.

Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
Measure Participants	33
Number (95% Confidence Interval) [percentage of participants]	12 36.4%

3. Secondary Outcome

Title	Response Rate
Description	Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time Frame	up to 3 years or time of disease progression

Outcome Measure Data

Analysis Population Description

All eligible patients who started protocol treatment were included in the analysis.

Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
Measure Participants	33
Complete Response	6 18.2%
Unconfirmed Complete Response	2 6.1%
Partial Response	5 15.2%
No Response	20 60.6%

4. Secondary Outcome

Title	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Description	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame	up to 18 weeks of protocol treatment

Outcome Measure Data

Analysis Population Description

Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
Measure Participants	33
Albumin, serum-low (hypoalbuminemia)	1 3%
Allergic reaction/hypersensitivity	1 3%
Anorexia	2 6.1%
Ataxia (incoordination)	1 3%
Auditory/Ear-Other (Specify)	1 3%
Blood/Bone Marrow-Other (Specify)	1 3%
Colitis, infectious (e.g., Clostridium difficile)	2 6.1%
Creatinine	2 6.1%
Diarrhea	2 6.1%
Dysphagia (difficulty swallowing)	1 3%
Dyspnea (shortness of breath)	1 3%
Fatigue (asthenia, lethargy, malaise)	2 6.1%
Febrile neutropenia	4 12.1%
Gastrointestinal-Other (Specify)	1 3%
Glucose, serum-high (hyperglycemia)	4 12.1%
Glucose, serum-low (hypoglycemia)	1 3%
Hemoglobin	9 27.3%
Hemorrhage, CNS	1 3%
Hypotension	2 6.1%
Incontinence, anal	1 3%
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	1 3%
Inf (clin/microbio) w/Gr 3-4 neuts - Colon	1 3%
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	1 3%
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1 3%
Leukocytes (total WBC)	8 24.2%
Lymphopenia	7 21.2%
Magnesium, serum-low (hypomagnesemia)	2 6.1%
Nausea	1 3%
Neurology-Other (Specify)	1 3%
Neuropathy: motor	1 3%
Neuropathy: sensory	2 6.1%
Neutrophils/granulocytes (ANC/AGC)	16 48.5%
Pain - Abdomen NOS	1 3%
Platelets	8 24.2%
Potassium, serum-low (hypokalemia)	1 3%
Renal failure	2 6.1%
Sodium, serum-low (hyponatremia)	2 6.1%
Thrombotic microangiopathy	1 3%
Tinnitus	1 3%
Tumor lysis syndrome	1 3%
Uric acid, serum-high (hyperuricemia)	1 3%

Adverse Events

Time Frame	up to 18 weeks of protocol treatment
Arm/Group Title	PEGS
Arm/Group Description	Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
All Cause Mortality
	PEGS
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PEGS
	Affected / at Risk (%)	# Events
Total	5/33 (15.2%)
Blood and lymphatic system disorders
Thrombotic microangiopathy	1/33 (3%)
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	1/33 (3%)
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)	1/33 (3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS	1/33 (3%)
Nervous system disorders
Hemorrhage, CNS	1/33 (3%)
Other (Not Including Serious) Adverse Events
	PEGS
	Affected / at Risk (%)	# Events
Total	33/33 (100%)
Blood and lymphatic system disorders
Febrile neutropenia	5/33 (15.2%)
Hemoglobin	28/33 (84.8%)
Cardiac disorders
Cardiac General-Other	3/33 (9.1%)
Palpitations	2/33 (6.1%)
SVT and nodal arrhythmia - Sinus bradycardia	2/33 (6.1%)
SVT and nodal arrhythmia - Sinus tachycardia	3/33 (9.1%)
Ear and labyrinth disorders
Auditory/Ear-Other	2/33 (6.1%)
Tinnitus	5/33 (15.2%)
Eye disorders
Ocular/Visual-Other	2/33 (6.1%)
Gastrointestinal disorders
Ascites (non-malignant)	2/33 (6.1%)
Constipation	11/33 (33.3%)
Diarrhea	14/33 (42.4%)
Distention/bloating, abdominal	3/33 (9.1%)
Dysphagia (difficulty swallowing)	2/33 (6.1%)
Heartburn/dyspepsia	5/33 (15.2%)
Mucositis/stomatitis (clinical exam) - Oral cavity	4/33 (12.1%)
Nausea	24/33 (72.7%)
Pain - Abdomen NOS	8/33 (24.2%)
Vomiting	11/33 (33.3%)
General disorders
Edema: head and neck	2/33 (6.1%)
Edema: limb	16/33 (48.5%)
Edema: trunk/genital	2/33 (6.1%)
Fatigue (asthenia, lethargy, malaise)	21/33 (63.6%)
Fever in absence of neutropenia, ANC lt1.0x10e9/L	6/33 (18.2%)
Injection site reaction/extravasation changes	2/33 (6.1%)
Pain - Chest/thorax NOS	2/33 (6.1%)
Pain-Other	9/33 (27.3%)
Rigors/chills	6/33 (18.2%)
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)	2/33 (6.1%)
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	2/33 (6.1%)
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	2/33 (6.1%)
Inf w/normal ANC or Gr 1-2 neutrophils - Skin	3/33 (9.1%)
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)	2/33 (6.1%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	4/33 (12.1%)
AST, SGOT	7/33 (21.2%)
Alkaline phosphatase	7/33 (21.2%)
Bilirubin (hyperbilirubinemia)	3/33 (9.1%)
Creatinine	15/33 (45.5%)
INR (of prothrombin time)	2/33 (6.1%)
Leukocytes (total WBC)	20/33 (60.6%)
Lymphopenia	11/33 (33.3%)
Metabolic/Laboratory-Other	2/33 (6.1%)
Neutrophils/granulocytes (ANC/AGC)	21/33 (63.6%)
Platelets	18/33 (54.5%)
Weight gain	8/33 (24.2%)
Weight loss	4/33 (12.1%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	13/33 (39.4%)
Anorexia	10/33 (30.3%)
Calcium, serum-high (hypercalcemia)	2/33 (6.1%)
Calcium, serum-low (hypocalcemia)	8/33 (24.2%)
Dehydration	4/33 (12.1%)
Glucose, serum-high (hyperglycemia)	15/33 (45.5%)
Glucose, serum-low (hypoglycemia)	3/33 (9.1%)
Magnesium, serum-low (hypomagnesemia)	9/33 (27.3%)
Phosphate, serum-low (hypophosphatemia)	2/33 (6.1%)
Potassium, serum-high (hyperkalemia)	2/33 (6.1%)
Potassium, serum-low (hypokalemia)	4/33 (12.1%)
Sodium, serum-low (hyponatremia)	7/33 (21.2%)
Uric acid, serum-high (hyperuricemia)	4/33 (12.1%)
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general	6/33 (18.2%)
Pain - Back	6/33 (18.2%)
Pain - Bone	4/33 (12.1%)
Pain - Extremity-limb	4/33 (12.1%)
Pain - Muscle	2/33 (6.1%)
Pain - Neck	3/33 (9.1%)
Nervous system disorders
Dizziness	6/33 (18.2%)
Neurology-Other	4/33 (12.1%)
Neuropathy: sensory	11/33 (33.3%)
Ocular/Visual-Other	2/33 (6.1%)
Pain - Head/headache	6/33 (18.2%)
Seizure	2/33 (6.1%)
Taste alteration (dysgeusia)	5/33 (15.2%)
Psychiatric disorders
Confusion	4/33 (12.1%)
Insomnia	9/33 (27.3%)
Mood alteration - agitation	2/33 (6.1%)
Mood alteration - anxiety	9/33 (27.3%)
Mood alteration - depression	2/33 (6.1%)
Renal and urinary disorders
Glomerular filtration rate	2/33 (6.1%)
Renal failure	3/33 (9.1%)
Urinary frequency/urgency	2/33 (6.1%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	2/33 (6.1%)
Cough	8/33 (24.2%)
Dyspnea (shortness of breath)	12/33 (36.4%)
Hemorrhage, pulmonary/upper respiratory - Nose	2/33 (6.1%)
Hiccoughs (hiccups, singultus)	2/33 (6.1%)
Hypoxia	3/33 (9.1%)
Pleural effusion (non-malignant)	2/33 (6.1%)
Pulmonary/Upper Respiratory-Other	3/33 (9.1%)
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)	15/33 (45.5%)
Pruritus/itching	5/33 (15.2%)
Rash/desquamation	3/33 (9.1%)
Sweating (diaphoresis)	5/33 (15.2%)
Vascular disorders
Hypertension	7/33 (21.2%)
Hypotension	7/33 (21.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.