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Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00274924
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : February 24, 2014
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: filgrastim
Biological: rituximab
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: prednisone
Drug: vincristine
Enrollment 100
Recruitment Details Participants were recruited from Eastern Cooperative Oncology Group (ECOG) member institutions between 4/7/2006 and 8/5/2009.
Pre-assignment Details  
Arm/Group Title Group I (PET Positive) Group II (PET Negative) No Mid-Treatment PET
Hide Arm/Group Description Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles . Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total). Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
Period Title: Step 1 (R-CHOP X 3 Cycles)
Started 17 77 6
Treated 17 77 5
Eligible and Treated 13 63 4
Completed 13 63 0
Not Completed 4 14 6
Reason Not Completed
Patient ineligible             4             14             1
Did not start treatment             0             0             1
Adverse Event             0             0             1
Withdrawal by Subject             0             0             1
Lost to Follow-up             0             0             1
Other complicating disease             0             0             1
Period Title: Step 2 (Tx Based on Mid-treatment PET)
Started 17 [1] 76 [2] 0
Eligible and Treated 13 61 0
Completed 10 58 0
Not Completed 7 18 0
Reason Not Completed
Patient ineligible             4             15             0
Adverse Event             1             0             0
Withdrawal by Subject             1             0             0
Other complicating disease             1             0             0
Death             0             1             0
Lack of Efficacy             0             1             0
Alternative therapy             0             1             0
[1]
All patients who started step 2 therapy were included regardless of eligibility.
[2]
One patient withdrew from the study after step 1 treatment.
Arm/Group Title Group I (PET Positive) Group II (PET Negative) No Mid-Treatment PET Total
Hide Arm/Group Description Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles . Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total). Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival. Total of all reporting groups
Overall Number of Baseline Participants 13 63 4 80
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 63 participants 4 participants 80 participants
61
(20 to 70)
63
(36 to 74)
54
(33 to 60)
62
(20 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 63 participants 4 participants 80 participants
Female
4
  30.8%
28
  44.4%
2
  50.0%
34
  42.5%
Male
9
  69.2%
35
  55.6%
2
  50.0%
46
  57.5%
1.Primary Outcome
Title 2-year Progression-Free Survival (PFS)
Hide Description 2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.
Time Frame Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (PET Negative) Group II (PET Positive)
Hide Arm/Group Description:
Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
Overall Number of Participants Analyzed 61 13
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: probability
0.76
(0.65 to 0.84)
0.42
(0.19 to 0.63)
2.Secondary Outcome
Title 5-year Overall Survival
Hide Description 5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.
Time Frame Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (PET Negative) Group II (PET Positive)
Hide Arm/Group Description:
Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
Overall Number of Participants Analyzed 61 13
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: probability
0.77
(0.49 to 0.91)
0.69
(0.43 to 0.85)
Time Frame Assessed every 3 weeks while on R-CHOP treatment and every 2 weeks while on R-ICE treatment, and for 30 days after the end of treatment, up to 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Step 1 - All Treated Patients Step 2 - Mid-treatment PET Positive Step 2 - Mid-treatment PET Negative
Hide Arm/Group Description All treated patients regardless of eligibility. Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility. Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
All-Cause Mortality
Step 1 - All Treated Patients Step 2 - Mid-treatment PET Positive Step 2 - Mid-treatment PET Negative
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Step 1 - All Treated Patients Step 2 - Mid-treatment PET Positive Step 2 - Mid-treatment PET Negative
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   58/99 (58.59%)   17/17 (100.00%)   25/76 (32.89%) 
Blood and lymphatic system disorders       
Anemia  1  5/99 (5.05%)  7/17 (41.18%)  5/76 (6.58%) 
Febrile neutropenia  1  8/99 (8.08%)  0/17 (0.00%)  3/76 (3.95%) 
Cardiac disorders       
Sinus tachycardia  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Gastrointestinal disorders       
Constipation  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Dyspepsia  1  2/99 (2.02%)  1/17 (5.88%)  0/76 (0.00%) 
Nausea  1  3/99 (3.03%)  1/17 (5.88%)  0/76 (0.00%) 
Perforation, small bowel NOS  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Vomiting  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
General disorders       
Fatigue  1  4/99 (4.04%)  1/17 (5.88%)  1/76 (1.32%) 
Fever w/o neutropenia  1  1/99 (1.01%)  0/17 (0.00%)  1/76 (1.32%) 
Immune system disorders       
Cytokine release syndrome  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Infections and infestations       
Colitis, infectious (e.g. C.diff)  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Infection w/ gr3-4 neut, lung  1  1/99 (1.01%)  1/17 (5.88%)  0/76 (0.00%) 
Infection w/ gr3-4 neut, peritoneal  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Infection w/ gr3-4 neut, upper airway  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Infection w/ gr3-4 neut, urinary tract  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Infection w/ gr3-4 neut, vulva  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Infection Gr0-2 neut, joint  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Infection Gr0-2 neut, larynx  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Infection Gr0-2 neut, upper airway  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Infection w/ gr3-4 neut, blood  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Injury, poisoning and procedural complications       
Vascular access,Thrombosis/embolism  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Investigations       
Leukocytes decreased  1  35/99 (35.35%)  10/17 (58.82%)  14/76 (18.42%) 
Lymphopenia  1  9/99 (9.09%)  8/17 (47.06%)  6/76 (7.89%) 
Neutrophils decreased  1  41/99 (41.41%)  11/17 (64.71%)  12/76 (15.79%) 
Platelets decreased  1  8/99 (8.08%)  15/17 (88.24%)  5/76 (6.58%) 
Weight gain  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Coagulation-other  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Aspartate aminotransferase increased  1  1/99 (1.01%)  1/17 (5.88%)  0/76 (0.00%) 
Blood bilirubin increased  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  2/99 (2.02%)  0/17 (0.00%)  0/76 (0.00%) 
Hypocalcemia  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Hyperglycemia  1  5/99 (5.05%)  1/17 (5.88%)  1/76 (1.32%) 
Hypoglycemia  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Hypophosphatemia  1  1/99 (1.01%)  1/17 (5.88%)  0/76 (0.00%) 
Hypokalemia  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Hyponatremia  1  1/99 (1.01%)  0/17 (0.00%)  1/76 (1.32%) 
Tumor lysis syndrome  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Musculoskeletal and connective tissue disorders       
Bone, pain  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Nervous system disorders       
Neuropathy-motor  1  0/99 (0.00%)  0/17 (0.00%)  0/76 (0.00%) 
Neuropathy-sensory  1  0/99 (0.00%)  0/17 (0.00%)  0/76 (0.00%) 
Syncope  1  1/99 (1.01%)  1/17 (5.88%)  0/76 (0.00%) 
Head/headache  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Psychiatric disorders       
Insomnia  1  1/99 (1.01%)  0/17 (0.00%)  0/76 (0.00%) 
Renal and urinary disorders       
Cystitis  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
(ARDS)  1  0/99 (0.00%)  0/17 (0.00%)  1/76 (1.32%) 
Pneumonitis/pulmonary infiltrates  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Vascular disorders       
Hypotension  1  0/99 (0.00%)  1/17 (5.88%)  1/76 (1.32%) 
Thrombosis/thrombus/embolism  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Step 1 - All Treated Patients Step 2 - Mid-treatment PET Positive Step 2 - Mid-treatment PET Negative
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   97/99 (97.98%)   17/17 (100.00%)   75/76 (98.68%) 
Blood and lymphatic system disorders       
Anemia  1  73/99 (73.74%)  16/17 (94.12%)  57/76 (75.00%) 
Gastrointestinal disorders       
Constipation  1  52/99 (52.53%)  3/17 (17.65%)  14/76 (18.42%) 
Diarrhea w/o prior colostomy  1  16/99 (16.16%)  2/17 (11.76%)  9/76 (11.84%) 
Dyspepsia  1  6/99 (6.06%)  0/17 (0.00%)  0/76 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  9/99 (9.09%)  3/17 (17.65%)  4/76 (5.26%) 
Nausea  1  50/99 (50.51%)  10/17 (58.82%)  25/76 (32.89%) 
Salivary  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Vomiting  1  15/99 (15.15%)  4/17 (23.53%)  3/76 (3.95%) 
Abdomen, pain  1  9/99 (9.09%)  1/17 (5.88%)  0/76 (0.00%) 
Fistula oral cavity  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
General disorders       
Fatigue  1  71/99 (71.72%)  16/17 (94.12%)  50/76 (65.79%) 
Fever w/o neutropenia  1  0/99 (0.00%)  4/17 (23.53%)  2/76 (2.63%) 
Rigors/chills  1  6/99 (6.06%)  1/17 (5.88%)  0/76 (0.00%) 
Injection site reaction  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Edema limb  1  5/99 (5.05%)  0/17 (0.00%)  0/76 (0.00%) 
Pain NOS  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Immune system disorders       
Cytokine release syndrome  1  5/99 (5.05%)  0/17 (0.00%)  0/76 (0.00%) 
Infections and infestations       
Infection w/ unk ANC skin (cellulitis)  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Investigations       
Leukocytes decreased  1  39/99 (39.39%)  8/17 (47.06%)  25/76 (32.89%) 
Lymphopenia  1  11/99 (11.11%)  3/17 (17.65%)  10/76 (13.16%) 
Neutrophils decreased  1  25/99 (25.25%)  3/17 (17.65%)  8/76 (10.53%) 
Platelets decreased  1  23/99 (23.23%)  8/17 (47.06%)  13/76 (17.11%) 
Weight loss  1  6/99 (6.06%)  0/17 (0.00%)  0/76 (0.00%) 
Alkaline phosphatase increased  1  22/99 (22.22%)  7/17 (41.18%)  4/76 (5.26%) 
Alanine aminotransferase increased  1  12/99 (12.12%)  3/17 (17.65%)  9/76 (11.84%) 
Aspartate aminotransferase increased  1  20/99 (20.20%)  7/17 (41.18%)  15/76 (19.74%) 
Creatinine increased  1  5/99 (5.05%)  3/17 (17.65%)  1/76 (1.32%) 
Metabolic/Laboratory-other  1  0/99 (0.00%)  1/17 (5.88%)  1/76 (1.32%) 
Metabolism and nutrition disorders       
Anorexia  1  22/99 (22.22%)  6/17 (35.29%)  9/76 (11.84%) 
Hypoalbuminemia  1  11/99 (11.11%)  1/17 (5.88%)  8/76 (10.53%) 
Hypercalcemia  1  5/99 (5.05%)  0/17 (0.00%)  4/76 (5.26%) 
Hypocalcemia  1  10/99 (10.10%)  3/17 (17.65%)  4/76 (5.26%) 
Hyperglycemia  1  58/99 (58.59%)  9/17 (52.94%)  32/76 (42.11%) 
Hypoglycemia  1  5/99 (5.05%)  0/17 (0.00%)  0/76 (0.00%) 
Hypomagnesemia  1  0/99 (0.00%)  2/17 (11.76%)  2/76 (2.63%) 
Hypophosphatemia  1  0/99 (0.00%)  3/17 (17.65%)  1/76 (1.32%) 
Hypokalemia  1  6/99 (6.06%)  3/17 (17.65%)  1/76 (1.32%) 
Hyponatremia  1  0/99 (0.00%)  1/17 (5.88%)  2/76 (2.63%) 
Hyperuricemia  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back, pain  1  0/99 (0.00%)  1/17 (5.88%)  1/76 (1.32%) 
Bone, pain  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Extremity-limb, pain  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Muscle, pain  1  14/99 (14.14%)  0/17 (0.00%)  0/76 (0.00%) 
Nervous system disorders       
Taste disturbance  1  22/99 (22.22%)  3/17 (17.65%)  14/76 (18.42%) 
Dizziness  1  9/99 (9.09%)  2/17 (11.76%)  1/76 (1.32%) 
Extrapyramidal movement  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Memory impairment  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Neuropathy-sensory  1  50/99 (50.51%)  6/17 (35.29%)  39/76 (51.32%) 
Depressed level of consciousness  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Head/headache  1  14/99 (14.14%)  3/17 (17.65%)  2/76 (2.63%) 
Psychiatric disorders       
Insomnia  1  27/99 (27.27%)  2/17 (11.76%)  6/76 (7.89%) 
Renal and urinary disorders       
Urinary hemorrhage NOS  1  0/99 (0.00%)  2/17 (11.76%)  0/76 (0.00%) 
Cystitis  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Urinary frequency/urgency  1  0/99 (0.00%)  1/17 (5.88%)  1/76 (1.32%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  0/99 (0.00%)  1/17 (5.88%)  1/76 (1.32%) 
Cough  1  0/99 (0.00%)  2/17 (11.76%)  6/76 (7.89%) 
Dyspnea  1  9/99 (9.09%)  4/17 (23.53%)  6/76 (7.89%) 
Hiccoughs  1  0/99 (0.00%)  2/17 (11.76%)  0/76 (0.00%) 
Nasal cavity/paranasal sinus reaction  1  0/99 (0.00%)  2/17 (11.76%)  4/76 (5.26%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  58/99 (58.59%)  7/17 (41.18%)  31/76 (40.79%) 
Pruritus/itching  1  5/99 (5.05%)  1/17 (5.88%)  1/76 (1.32%) 
Rash/desquamation  1  6/99 (6.06%)  1/17 (5.88%)  1/76 (1.32%) 
Urticaria  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Vascular disorders       
Hypertension  1  5/99 (5.05%)  1/17 (5.88%)  0/76 (0.00%) 
Hypotension  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Flushing  1  7/99 (7.07%)  1/17 (5.88%)  1/76 (1.32%) 
Hot flashes  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Phlebitis  1  0/99 (0.00%)  1/17 (5.88%)  0/76 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
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.
Results Point of Contact
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Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00274924    
Other Study ID Numbers: CDR0000455012
U10CA021115 ( U.S. NIH Grant/Contract )
E3404 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: January 9, 2014
Results First Posted: February 24, 2014
Last Update Posted: November 17, 2020