Trial Outcomes & Findings for Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma (NCT NCT00121199)

Last Updated: 2014-05-21

Results Overview

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

0-1 year

Results posted on

2014-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	CHOP + Rituximab + Bevacizumab Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Study STARTED	73
Overall Study Eligible	64
Overall Study Eligible and Began Protocol Therapy	64
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	CHOP + Rituximab + Bevacizumab Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Overall Study Adverse Event	11
Overall Study Refusal Unrelated to Adverse Event	1
Overall Study Progression/Relapse	1
Overall Study Death	3
Overall Study Other - Not Protocol Specified	3
Overall Study Ineligible	9

Baseline Characteristics

Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHOP + Rituximab + Bevacizumab n=64 Participants Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Age, Continuous	67.6 years n=99 Participants
Sex: Female, Male Female	20 Participants n=99 Participants
Sex: Female, Male Male	44 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants
Race (NIH/OMB) White	54 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 0-1 year

Population: All eligible patients who started treatment were included in the analysis

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

Outcome measures

Outcome measures
Measure	CHOP + Rituximab + Bevacizumab n=64 Participants Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Progression-free Survival at 1 Year	77 percentage of participants Interval 66.0 to 87.0

PRIMARY outcome

Timeframe: 0-2 years

Population: All eligible patients who started treatment were included in the analysis

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

Outcome measures

Outcome measures
Measure	CHOP + Rituximab + Bevacizumab n=64 Participants Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Progression-free Survival at 2 Year	69 percentage of participants Interval 57.0 to 80.0

SECONDARY outcome

Timeframe: After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.

Population: All 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 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

Outcome measures
Measure	CHOP + Rituximab + Bevacizumab n=64 Participants Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) Complete Response (CR)	22 participants
Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) Partial Response (PR)	20 participants
Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) Unconfirmed Complete Response (UCR)	6 participants
Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) Unconfirmed Partial Response (UPR)	1 participants
Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) No Response	15 participants

SECONDARY outcome

Timeframe: Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol 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

Outcome measures
Measure	CHOP + Rituximab + Bevacizumab n=63 Participants Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Bone	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Throat/pharynx/larynx	1 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 Pneumothorax	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug ALT, SGPT (serum glutamic pyruvic transaminase)	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Allergic reaction/hypersensitivity	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Anorexia	5 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cardiac General-Other (Specify)	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 Cardiopulmonary arrest, cause unknown (non-fatal)	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Constipation	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Distention/bloating, abdominal	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dry mouth/salivary gland (xerostomia)	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dyspnea (shortness of breath)	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	8 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Febrile neutropenia	11 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fever in absence of neutropenia, ANC lt1.0x10e9/L	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Glucose, serum-high (hyperglycemia)	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemoglobin	8 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 - Lung	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 - Skin	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 - Skin	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 Insomnia	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Left ventricular diastolic dysfunction	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Left ventricular systolic dysfunction	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Nausea	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neuropathy: motor	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neuropathy: sensory	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 Hemolysis	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, GI - Colon	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, pulmonary/upper respiratory - Nose	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypertension	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypotension	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypoxia	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	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 - Ab NOS	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	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	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Leukocytes (total WBC)	28 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Lymphopenia	10 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mucositis/stomatitis (clinical exam) - Oral cavity	2 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	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neutrophils/granulocytes (ANC/AGC)	33 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Obstruction, GI - Jejunum	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Abdomen NOS	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Perforation, GI - Jejunum	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Perforation, GI - Small bowel NOS	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Perforation, GI - Stomach	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Platelets	12 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 Pruritus/itching	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pulmonary/Upper Respiratory-Other (Specify)	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 Sodium, serum-low (hyponatremia)	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Somnolence/depressed level of consciousness	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Sudden death	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thrombosis/thrombus/embolism	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Voice changes/dysarthria	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vomiting	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Weight loss	1 Participants

Adverse Events

CHOP + Rituximab + Bevacizumab

Serious events: 27 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CHOP + Rituximab + Bevacizumab n=63 participants at risk Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	4.8% 3/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Blood and lymphatic system disorders Hemoglobin	4.8% 3/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Cardiac disorders Left ventricular systolic dysfunction	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Constipation	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Diarrhea	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Distention/bloating, abdominal	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Hemorrhage, GI - Colon	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Esophagus	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Nausea	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Pain - Abdomen NOS	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Perforation, GI - Jejunum	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Perforation, GI - Small bowel NOS	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Perforation, GI - Stomach	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Vomiting	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Fatigue (asthenia, lethargy, malaise)	4.8% 3/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Pain-Other (Specify)	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Sudden death	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Lung	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Skin	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Blood	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lung	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lymphatic	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - UTI	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Injury, poisoning and procedural complications Fracture	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Leukocytes (total WBC)	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Lymphopenia	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Neutrophils/granulocytes (ANC/AGC)	11.1% 7/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Platelets	4.8% 3/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Anorexia	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Dehydration	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Bone	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Neuropathy: motor	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Pain - Head/headache	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome (ARDS)	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	3.2% 2/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Vascular disorders Hypertension	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Vascular disorders Hypotension	1.6% 1/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Vascular disorders Thrombosis/thrombus/embolism	4.8% 3/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment

Other adverse events

Other adverse events
Measure	CHOP + Rituximab + Bevacizumab n=63 participants at risk Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	12.7% 8/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Blood and lymphatic system disorders Hemoglobin	66.7% 42/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Cardiac disorders Left ventricular systolic dysfunction	12.7% 8/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Constipation	47.6% 30/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Diarrhea	30.2% 19/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	7.9% 5/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Dysphagia (difficulty swallowing)	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Heartburn/dyspepsia	11.1% 7/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Hemorrhoids	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	31.7% 20/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	19.0% 12/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Nausea	39.7% 25/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Pain - Abdomen NOS	20.6% 13/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Gastrointestinal disorders Vomiting	15.9% 10/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Edema: limb	14.3% 9/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Fatigue (asthenia, lethargy, malaise)	74.6% 47/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	20.6% 13/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Pain-Other (Specify)	14.3% 9/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
General disorders Rigors/chills	19.0% 12/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	20.6% 13/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations AST, SGOT	23.8% 15/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Alkaline phosphatase	15.9% 10/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Bilirubin (hyperbilirubinemia)	9.5% 6/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Creatinine	12.7% 8/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Leukocytes (total WBC)	50.8% 32/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Lymphopenia	25.4% 16/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Neutrophils/granulocytes (ANC/AGC)	50.8% 32/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Platelets	41.3% 26/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Investigations Weight loss	22.2% 14/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	28.6% 18/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Anorexia	38.1% 24/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	22.2% 14/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Dehydration	12.7% 8/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	42.9% 27/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	7.9% 5/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	9.5% 6/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	14.3% 9/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	27.0% 17/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue-Other (Specify)	7.9% 5/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Back	22.2% 14/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Bone	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Joint	15.9% 10/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Muscle	12.7% 8/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Dizziness	9.5% 6/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Neuropathy: motor	7.9% 5/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Neuropathy: sensory	50.8% 32/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Pain - Head/headache	22.2% 14/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Nervous system disorders Taste alteration (dysgeusia)	17.5% 11/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Psychiatric disorders Insomnia	17.5% 11/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Psychiatric disorders Mood alteration - anxiety	7.9% 5/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	11.1% 7/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Cough	19.0% 12/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	30.2% 19/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	23.8% 15/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other (Specify)	7.9% 5/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	9.5% 6/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Skin and subcutaneous tissue disorders Dermatology/Skin-Other (Specify)	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	39.7% 25/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Skin and subcutaneous tissue disorders Nail changes	6.3% 4/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	14.3% 9/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Vascular disorders Hypertension	12.7% 8/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
Vascular disorders Hypotension	9.5% 6/63 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol 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

Restriction type: LTE60