Trial Outcomes & Findings for S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma (NCT NCT00107380)
NCT ID: NCT00107380
Last Updated: 2016-03-07
Results Overview
Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
0-2 years
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
R-CHOP + I-131-tositumomab
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
Eligible
|
84
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
R-CHOP + I-131-tositumomab
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Refusal Unrelated to Adverse Event
|
7
|
|
Overall Study
Progression/relapse
|
4
|
|
Overall Study
Death
|
3
|
|
Overall Study
Other - not protocol specified
|
7
|
|
Overall Study
Ineligible
|
2
|
Baseline Characteristics
S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
R-CHOP + I-131-tositumomab
n=84 Participants
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
|
|---|---|
|
Age, Continuous
|
63.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started treatment were included in the analysis
Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
R-CHOP + I-131-tositumomab
n=84 Participants
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
|
|---|---|
|
Progression-free Survival (PFS) at 2 Years
|
69 percentage of participants
Interval 59.0 to 79.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All eligible patients who started treatment were included in the analysis
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.
Outcome measures
| Measure |
R-CHOP + I-131-tositumomab
n=84 Participants
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
|
|---|---|
|
Response Rate (Complete, Complete Unconfirmed, and Partial)
Partial Response
|
21 participants
|
|
Response Rate (Complete, Complete Unconfirmed, and Partial)
Confirmed Response
|
41 participants
|
|
Response Rate (Complete, Complete Unconfirmed, and Partial)
Unconfirmed Response
|
10 participants
|
|
Response Rate (Complete, Complete Unconfirmed, and Partial)
No Response
|
12 participants
|
SECONDARY outcome
Timeframe: 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)Population: 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.
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.
Outcome measures
| Measure |
R-CHOP + I-131-tositumomab
n=84 Participants
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
|
|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac-ischemia/infarction
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Constipation
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cough
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Calcium, serum-low (hypocalcemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac troponin I (cTnI)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dehydration
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dizziness
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
12 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
14 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Gastrointestinal-Other (Specify: GI bleed)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hearing: pts w/o audiogram not enroll monitor prgm
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
12 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GI - Rectum
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GU - Urinary NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Dental
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Left ventricular systolic dysfunction
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
47 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
39 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - anxiety
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nausea
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neurology-Other (Specify: restless leg syndrom)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
8 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
55 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Back
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Esophagus
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Head/headache
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Phosphate, serum-low (hypophosphatemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
29 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Renal failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Restrictive cardiomyopathy
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - SVT tachycardia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Secondary Malignancy-poss rel to cancer Tx
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Uric acid, serum-high (hyperuricemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vision-blurred vision
|
1 Participants
|
Adverse Events
R-CHOP + I-131-tositumomab
Serious events: 8 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R-CHOP + I-131-tositumomab
n=84 participants at risk
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
1/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
2.4%
2/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
1.2%
1/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
1.2%
1/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
1.2%
1/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Platelets
|
1.2%
1/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-poss rel to cancer Tx
|
2.4%
2/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
Other adverse events
| Measure |
R-CHOP + I-131-tositumomab
n=84 participants at risk
Patients receive cyclophosphamide 750 mg/m\^2 IV over 15 minutes, doxorubicin 50 mg/m\^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m\^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m\^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.5%
13/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
83.3%
70/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Eye disorders
Vision-blurred vision
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Constipation
|
47.6%
40/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Diarrhea
|
26.2%
22/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
8.3%
7/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
17.9%
15/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
14.3%
12/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Nausea
|
53.6%
45/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
23.8%
20/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
12/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Constitutional Symptoms-Other (Specify)
|
7.1%
6/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Edema: head and neck
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Edema: limb
|
23.8%
20/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
85.7%
72/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
21.4%
18/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Pain-Other (Specify)
|
13.1%
11/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
General disorders
Rigors/chills
|
13.1%
11/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
10.7%
9/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
23.8%
20/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
AST, SGOT
|
32.1%
27/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Alkaline phosphatase
|
15.5%
13/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Creatinine
|
21.4%
18/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Leukocytes (total WBC)
|
83.3%
70/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Lymphopenia
|
64.3%
54/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
9.5%
8/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
81.0%
68/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Platelets
|
73.8%
62/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Weight gain
|
7.1%
6/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Investigations
Weight loss
|
22.6%
19/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
21.4%
18/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Anorexia
|
27.4%
23/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
13.1%
11/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
6/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
56.0%
47/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
9.5%
8/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
11.9%
10/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
10.7%
9/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
17.9%
15/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
17.9%
15/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
21.4%
18/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
15.5%
13/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
16.7%
14/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
14.3%
12/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Nervous system disorders
Dizziness
|
21.4%
18/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Nervous system disorders
Neuropathy: motor
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Nervous system disorders
Neuropathy: sensory
|
57.1%
48/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Nervous system disorders
Pain - Head/headache
|
26.2%
22/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
20.2%
17/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Psychiatric disorders
Insomnia
|
27.4%
23/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Psychiatric disorders
Mood alteration - agitation
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Psychiatric disorders
Mood alteration - anxiety
|
21.4%
18/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Psychiatric disorders
Mood alteration - depression
|
15.5%
13/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
9.5%
8/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.5%
13/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
24/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
27.4%
23/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
8.3%
7/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
9.5%
8/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
6/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
60.7%
51/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.1%
6/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.5%
13/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.0%
5/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
16.7%
14/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
|
Vascular disorders
Hypotension
|
16.7%
14/84 • 6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place