Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT01190449
Collaborator
National Cancer Institute (NCI) (NIH)
51
48
2
110.5
1.1
0

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: ofatumumab
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • To determine the response rate in patients with previously untreated CD20-positive bulky stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a lower- or high-dose of ofatumumab.

Secondary

  • To determine the progression-free survival (PFS) of patients treated with these regimens.

  • To determine the toxicity profile of these regimens in these patients.

  • To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic doublet trials.

  • To evaluate the two ofatumumab doses by independent comparison of response, PFS, and toxicity to a historical control in previously untreated patients with follicular NHL.

  • To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk patients and compare to low- and intermediate-risk stratified patients by standard FLIPI scoring to determine a more reliable indicator of response and PFS.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

  • Arm II: Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and bone marrow sample collection for correlative studies.

After completion of study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 8 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Ofatumumab (CALGB IND #) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Actual Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Oct 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

Biological: ofatumumab
Given IV

Experimental: Arm II

Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

Biological: ofatumumab
Given IV

Outcome Measures

Primary Outcome Measures

  1. Overall Response Rate (Complete or Partial Response) by Month 12 [From baseline to month 12]

    The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.

Secondary Outcome Measures

  1. Median Progression-free Survival Time [From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years]

    The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically confirmed follicular non-Hodgkin lymphoma (NHL) meeting 1 of the following criteria:

  • Bulky (i.e., single mass ≥ 7cm in any uni-dimensional measurement) stage II disease

  • Stage III or IV disease

  • WHO grade 1, 2, or 3a disease

  • Bone marrow biopsies allowed provided they are submitted in conjunction with nodal biopsies

  • No fine-needle aspirates for diagnosis

  • Tumor tissue must express the CD20-positive antigen by flow cytometry or IHC

  • At least 1 site of measurable disease that is > 1 cm in diameter in ≥ 1 dimension present either on physical exam or imaging studies

  • Non-measurable disease alone not allowed, including the following:

  • Bone lesions (lesions if present should be noted)

  • Ascites

  • Pleural/pericardial effusion

  • Lymphangitis cutis/pulmonis

  • Bone marrow (involvement by NHL should be noted)

  • Low- or intermediate-risk disease by the Follicular Lymphoma International Prognostic Index (FLIPI)

  • FLIPI score meeting 1 or 2 of the following risk factors:

  • Age > 60 years

  • Involvement of > 4 nodal sites

  • Stage III-IV disease

  • Hemoglobin < 12.0 g/dL

  • LDH normal

  • Risk determined by the following:

  • Low Risk: 0-1 of the above risk factors

  • Intermediate Risk: 2 risk factors

  • Poor Risk: ≥ 3 risk factors

  • No known CNS involvement

PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2

  • ANC ≥ 1,000/μL

  • Platelet count ≥ 75,000/μL

  • Creatinine clearance ≥ 30 mL/min

  • Bilirubin ≤ 2 times upper limit of normal (unless secondary to Gilbert syndrome or hepatic involvement of NHL)

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment

  • Patients with HIV infection allowed provided the following criteria are met:

  • No evidence of coinfection with hepatitis B or C

  • CD4+ cell count ≥ 400/mm³

  • No evidence of resistant strains of HIV

  • HIV viral load < 10,000 copies HIV RNA/mL if not on anti-HIV therapy OR HIV viral load < 50 copies if on anti-HIV therapy

  • No history of AIDS-defining conditions

  • No evidence of active hepatitis B (HBV) or C (HCV) infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies)

  • HBV seropositivity allowed (HBsAg+) provided they are closely monitored for evidence of active HBV infection by HBV DNA testing

  • After completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine (required)

PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for NHL

  • Prior involved-field radiation therapy allowed

  • More than 2 weeks since prior corticosteroids except for maintenance therapy for a non-malignant disease

  • No concurrent dexamethasone or other steroids as antiemetics

  • No live virus vaccination within 6 weeks prior to study entry

  • No concurrent zidvoudine or stavudine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
2 CCOP - Christiana Care Health Services Newark Delaware United States 19713
3 Cleveland Clinic Florida - Weston Weston Florida United States 33331
4 Illinois CancerCare - Bloomington Bloomington Illinois United States 61701
5 Illinois CancerCare - Canton Canton Illinois United States 61520
6 Eureka Community Hospital Eureka Illinois United States 61530
7 Illinois CancerCare - Eureka Eureka Illinois United States 61530
8 Galesburg Clinic, PC Galesburg Illinois United States 61401
9 Illinois CancerCare - Macomb Macomb Illinois United States 61455
10 BroMenn Regional Medical Center Normal Illinois United States 61761
11 Community Cancer Center Normal Illinois United States 61761
12 Illinois CancerCare - Community Cancer Center Normal Illinois United States 61761
13 Community Hospital of Ottawa Ottawa Illinois United States 61350
14 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
15 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
16 Illinois CancerCare - Pekin Pekin Illinois United States 61603
17 Proctor Hospital Peoria Illinois United States 61614
18 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
19 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
20 Methodist Medical Center of Illinois Peoria Illinois United States 61636
21 Illinois CancerCare - Peru Peru Illinois United States 61354
22 Illinois Valley Community Hospital Peru Illinois United States 61354
23 Illinois CancerCare - Spring Valley Spring Valley Illinois United States 61362
24 Iowa Blood and Cancer Care Cedar Rapids Iowa United States 52402
25 Union Hospital of Cecil County Elkton Maryland United States 21921
26 Battle Creek Health System Cancer Care Center Battle Creek Michigan United States 49017
27 Mecosta County Medical Center Big Rapids Michigan United States 49307
28 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503
29 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
30 Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan United States 49503
31 Mercy General Health Partners Muskegon Michigan United States 49444
32 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
33 Munson Medical Center Traverse City Michigan United States 49684
34 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri United States 63110
35 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire United States 03301
36 New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire United States 03106
37 Lakes Region General Hospital Laconia New Hampshire United States 03246
38 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
39 Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York United States 11042
40 Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York United States 11030
41 Mount Kisco Medical Group, PC Mount Kisco New York United States 10549-3417
42 Long Island Jewish Medical Center New Hyde Park New York United States 11040
43 New York Weill Cornell Cancer Center at Cornell University New York New York United States 10021
44 SUNY Upstate Medical University Hospital Syracuse New York United States 13210
45 Kinston Medical Specialists Kinston North Carolina United States 28501
46 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
47 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210-1240
48 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cara A. Rosenbaum, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01190449
Other Study ID Numbers:
  • CALGB-50901
  • CALGB-50901
  • GSK-CALGB-50901
  • CDR0000683083
First Posted:
Aug 27, 2010
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Period Title: Overall Study
STARTED 15 36
COMPLETED 15 32
NOT COMPLETED 0 4

Baseline Characteristics

Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab) Total
Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Total of all reporting groups
Overall Participants 15 36 51
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
63
58
60
Sex: Female, Male (Count of Participants)
Female
4
26.7%
19
52.8%
23
45.1%
Male
11
73.3%
17
47.2%
28
54.9%
Region of Enrollment (Count of Participants)
United States
15
100%
36
100%
51
100%

Outcome Measures

1. Primary Outcome
Title Overall Response Rate (Complete or Partial Response) by Month 12
Description The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.
Time Frame From baseline to month 12

Outcome Measure Data

Analysis Population Description
Patients who completed the study and were not ineligible were included in this analysis.
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Measure Participants 15 32
Number (95% Confidence Interval) [percentage of patients]
60
84
2. Secondary Outcome
Title Median Progression-free Survival Time
Description The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis.
Time Frame From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years

Outcome Measure Data

Analysis Population Description
Patients who completed the study and were not ineligible were included in this analysis.
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Measure Participants 15 32
Median (95% Confidence Interval) [years]
1.9
1.9

Adverse Events

Time Frame From baseline to month 12
Adverse Event Reporting Description Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
All Cause Mortality
Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/36 (0%)
Serious Adverse Events
Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/15 (13.3%) 8/36 (22.2%)
Cardiac disorders
Acute coronary syndrome 0/15 (0%) 0 1/36 (2.8%) 1
Gastrointestinal disorders
Small intestinal obstruction 0/15 (0%) 0 1/36 (2.8%) 1
General disorders
Fatigue 0/15 (0%) 0 1/36 (2.8%) 1
Infusion related reaction 0/15 (0%) 0 3/36 (8.3%) 3
Infections and infestations
Bone infection 1/15 (6.7%) 1 0/36 (0%) 0
Infections and infestations - Other, specify 1/15 (6.7%) 1 0/36 (0%) 0
Investigations
Lymphocyte count decreased 1/15 (6.7%) 1 2/36 (5.6%) 2
White blood cell decreased 0/15 (0%) 0 1/36 (2.8%) 1
Respiratory, thoracic and mediastinal disorders
Pneumonitis 0/15 (0%) 0 1/36 (2.8%) 1
Other (Not Including Serious) Adverse Events
Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 15/15 (100%) 35/36 (97.2%)
Blood and lymphatic system disorders
Anemia 2/15 (13.3%) 5 6/36 (16.7%) 23
Leukocytosis 1/15 (6.7%) 1 0/36 (0%) 0
Lymph node pain 1/15 (6.7%) 1 1/36 (2.8%) 1
Cardiac disorders
Aortic valve disease 1/15 (6.7%) 4 0/36 (0%) 0
Cardiac disorders - Other, specify 0/15 (0%) 0 1/36 (2.8%) 4
Palpitations 0/15 (0%) 0 1/36 (2.8%) 1
Sinus bradycardia 0/15 (0%) 0 1/36 (2.8%) 1
Ear and labyrinth disorders
Ear pain 0/15 (0%) 0 1/36 (2.8%) 1
Hearing impaired 0/15 (0%) 0 1/36 (2.8%) 1
Tinnitus 1/15 (6.7%) 2 0/36 (0%) 0
Vertigo 0/15 (0%) 0 1/36 (2.8%) 1
Eye disorders
Blurred vision 1/15 (6.7%) 1 0/36 (0%) 0
Eye disorders - Other, specify 0/15 (0%) 0 1/36 (2.8%) 1
Gastrointestinal disorders
Abdominal pain 1/15 (6.7%) 1 7/36 (19.4%) 20
Bloating 0/15 (0%) 0 1/36 (2.8%) 3
Constipation 1/15 (6.7%) 1 4/36 (11.1%) 7
Dental caries 0/15 (0%) 0 2/36 (5.6%) 8
Diarrhea 2/15 (13.3%) 2 7/36 (19.4%) 18
Dyspepsia 0/15 (0%) 0 6/36 (16.7%) 18
Flatulence 1/15 (6.7%) 4 0/36 (0%) 0
Gastritis 0/15 (0%) 0 1/36 (2.8%) 1
Gastroesophageal reflux disease 1/15 (6.7%) 1 4/36 (11.1%) 7
Mucositis oral 1/15 (6.7%) 2 0/36 (0%) 0
Nausea 3/15 (20%) 8 13/36 (36.1%) 29
Rectal hemorrhage 0/15 (0%) 0 1/36 (2.8%) 1
Vomiting 0/15 (0%) 0 2/36 (5.6%) 2
General disorders
Chills 1/15 (6.7%) 1 4/36 (11.1%) 11
Edema limbs 1/15 (6.7%) 2 3/36 (8.3%) 10
Edema trunk 1/15 (6.7%) 1 0/36 (0%) 0
Fatigue 11/15 (73.3%) 32 23/36 (63.9%) 75
Fever 1/15 (6.7%) 1 4/36 (11.1%) 5
Flu like symptoms 0/15 (0%) 0 1/36 (2.8%) 1
General disorders and administration site conditions - Other, specify 0/15 (0%) 0 2/36 (5.6%) 2
Infusion related reaction 13/15 (86.7%) 19 29/36 (80.6%) 33
Malaise 0/15 (0%) 0 1/36 (2.8%) 1
Neck edema 0/15 (0%) 0 1/36 (2.8%) 1
Non-cardiac chest pain 0/15 (0%) 0 1/36 (2.8%) 1
Pain 1/15 (6.7%) 2 4/36 (11.1%) 9
Immune system disorders
Allergic reaction 1/15 (6.7%) 3 1/36 (2.8%) 2
Cytokine release syndrome 1/15 (6.7%) 1 2/36 (5.6%) 2
Infections and infestations
Bronchial infection 1/15 (6.7%) 1 2/36 (5.6%) 3
Infections and infestations - Other, specify 2/15 (13.3%) 2 2/36 (5.6%) 2
Sinusitis 0/15 (0%) 0 1/36 (2.8%) 1
Skin infection 0/15 (0%) 0 1/36 (2.8%) 1
Upper respiratory infection 0/15 (0%) 0 4/36 (11.1%) 4
Urinary tract infection 1/15 (6.7%) 1 4/36 (11.1%) 4
Vaginal infection 0/15 (0%) 0 1/36 (2.8%) 1
Injury, poisoning and procedural complications
Bruising 0/15 (0%) 0 2/36 (5.6%) 2
Fall 2/15 (13.3%) 2 0/36 (0%) 0
Injury, poisoning and procedural complications - Other, specify 0/15 (0%) 0 1/36 (2.8%) 1
Investigations
Alanine aminotransferase increased 0/15 (0%) 0 5/36 (13.9%) 7
Alkaline phosphatase increased 0/15 (0%) 0 1/36 (2.8%) 5
Aspartate aminotransferase increased 1/15 (6.7%) 1 2/36 (5.6%) 3
Blood bilirubin increased 0/15 (0%) 0 3/36 (8.3%) 11
Creatinine increased 1/15 (6.7%) 2 3/36 (8.3%) 5
Lymphocyte count decreased 3/15 (20%) 17 11/36 (30.6%) 41
Neutrophil count decreased 0/15 (0%) 0 6/36 (16.7%) 12
Platelet count decreased 2/15 (13.3%) 9 2/36 (5.6%) 11
Weight gain 1/15 (6.7%) 2 3/36 (8.3%) 7
Weight loss 0/15 (0%) 0 1/36 (2.8%) 1
White blood cell decreased 2/15 (13.3%) 5 10/36 (27.8%) 26
Metabolism and nutrition disorders
Anorexia 3/15 (20%) 4 2/36 (5.6%) 3
Dehydration 0/15 (0%) 0 2/36 (5.6%) 2
Hypercalcemia 0/15 (0%) 0 1/36 (2.8%) 6
Hyperglycemia 5/15 (33.3%) 10 12/36 (33.3%) 46
Hyperkalemia 1/15 (6.7%) 2 2/36 (5.6%) 3
Hypernatremia 0/15 (0%) 0 1/36 (2.8%) 1
Hyperuricemia 0/15 (0%) 0 3/36 (8.3%) 9
Hypoalbuminemia 3/15 (20%) 7 3/36 (8.3%) 5
Hypocalcemia 2/15 (13.3%) 2 3/36 (8.3%) 3
Hypoglycemia 1/15 (6.7%) 4 1/36 (2.8%) 1
Hypokalemia 1/15 (6.7%) 2 2/36 (5.6%) 2
Hypomagnesemia 0/15 (0%) 0 1/36 (2.8%) 1
Hyponatremia 4/15 (26.7%) 4 6/36 (16.7%) 12
Hypophosphatemia 2/15 (13.3%) 3 5/36 (13.9%) 6
Musculoskeletal and connective tissue disorders
Arthralgia 1/15 (6.7%) 1 6/36 (16.7%) 16
Arthritis 0/15 (0%) 0 3/36 (8.3%) 5
Back pain 5/15 (33.3%) 12 3/36 (8.3%) 3
Bone pain 0/15 (0%) 0 1/36 (2.8%) 1
Buttock pain 1/15 (6.7%) 1 0/36 (0%) 0
Chest wall pain 0/15 (0%) 0 1/36 (2.8%) 1
Generalized muscle weakness 0/15 (0%) 0 1/36 (2.8%) 1
Musculoskeletal and connective tissue disorder - Other, specify 0/15 (0%) 0 1/36 (2.8%) 1
Myalgia 2/15 (13.3%) 2 3/36 (8.3%) 4
Neck pain 0/15 (0%) 0 1/36 (2.8%) 1
Pain in extremity 3/15 (20%) 6 3/36 (8.3%) 6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain 1/15 (6.7%) 5 1/36 (2.8%) 1
Nervous system disorders
Brachial plexopathy 0/15 (0%) 0 1/36 (2.8%) 2
Dizziness 1/15 (6.7%) 1 5/36 (13.9%) 9
Dysarthria 0/15 (0%) 0 1/36 (2.8%) 1
Dysgeusia 1/15 (6.7%) 4 0/36 (0%) 0
Headache 2/15 (13.3%) 12 9/36 (25%) 19
Memory impairment 0/15 (0%) 0 1/36 (2.8%) 2
Peripheral sensory neuropathy 1/15 (6.7%) 2 3/36 (8.3%) 9
Presyncope 0/15 (0%) 0 1/36 (2.8%) 2
Sinus pain 0/15 (0%) 0 1/36 (2.8%) 1
Syncope 0/15 (0%) 0 1/36 (2.8%) 1
Psychiatric disorders
Anxiety 1/15 (6.7%) 7 5/36 (13.9%) 16
Confusion 1/15 (6.7%) 2 1/36 (2.8%) 1
Depression 1/15 (6.7%) 1 2/36 (5.6%) 11
Insomnia 4/15 (26.7%) 6 11/36 (30.6%) 29
Restlessness 0/15 (0%) 0 2/36 (5.6%) 3
Renal and urinary disorders
Chronic kidney disease 0/15 (0%) 0 2/36 (5.6%) 8
Urinary frequency 1/15 (6.7%) 1 1/36 (2.8%) 1
Urinary tract obstruction 0/15 (0%) 0 1/36 (2.8%) 1
Reproductive system and breast disorders
Genital edema 1/15 (6.7%) 2 0/36 (0%) 0
Pelvic pain 0/15 (0%) 0 1/36 (2.8%) 1
Reproductive system and breast disorders - Other, specify 1/15 (6.7%) 2 0/36 (0%) 0
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis 2/15 (13.3%) 2 3/36 (8.3%) 6
Bronchospasm 0/15 (0%) 0 2/36 (5.6%) 2
Cough 4/15 (26.7%) 9 7/36 (19.4%) 12
Dyspnea 6/15 (40%) 13 12/36 (33.3%) 27
Epistaxis 1/15 (6.7%) 1 1/36 (2.8%) 1
Hoarseness 0/15 (0%) 0 1/36 (2.8%) 1
Laryngopharyngeal dysesthesia 0/15 (0%) 0 1/36 (2.8%) 1
Nasal congestion 1/15 (6.7%) 1 2/36 (5.6%) 2
Postnasal drip 1/15 (6.7%) 1 3/36 (8.3%) 3
Productive cough 1/15 (6.7%) 1 1/36 (2.8%) 2
Respiratory, thoracic and mediastinal disorders - Other, specify 3/15 (20%) 6 0/36 (0%) 0
Sore throat 3/15 (20%) 3 2/36 (5.6%) 2
Skin and subcutaneous tissue disorders
Alopecia 0/15 (0%) 0 1/36 (2.8%) 1
Dry skin 0/15 (0%) 0 5/36 (13.9%) 11
Erythema multiforme 0/15 (0%) 0 2/36 (5.6%) 2
Hyperhidrosis 2/15 (13.3%) 5 2/36 (5.6%) 4
Pruritus 2/15 (13.3%) 3 7/36 (19.4%) 12
Rash acneiform 0/15 (0%) 0 3/36 (8.3%) 3
Rash maculo-papular 1/15 (6.7%) 1 2/36 (5.6%) 2
Skin and subcutaneous tissue disorders - Other, specify 1/15 (6.7%) 1 0/36 (0%) 0
Urticaria 1/15 (6.7%) 2 4/36 (11.1%) 6
Vascular disorders
Flushing 0/15 (0%) 0 2/36 (5.6%) 5
Hot flashes 1/15 (6.7%) 2 2/36 (5.6%) 2
Hypertension 3/15 (20%) 13 11/36 (30.6%) 45
Hypotension 2/15 (13.3%) 2 2/36 (5.6%) 2
Lymphedema 0/15 (0%) 0 1/36 (2.8%) 2
Vascular disorders - Other, specify 0/15 (0%) 0 1/36 (2.8%) 7

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 Cara Rosenbaum, MD
Organization Weill Cornell Medicine Cornell University
Phone (646) 962-6500
Email car9156@med.cornell.edu
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01190449
Other Study ID Numbers:
  • CALGB-50901
  • CALGB-50901
  • GSK-CALGB-50901
  • CDR0000683083
First Posted:
Aug 27, 2010
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021