Trial Outcomes & Findings for S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas (NCT NCT00217620)

Last Updated: 2014-05-15

Results Overview

Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Assessment performed every eight weeks until progression.

Results posted on

2014-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib (BAY 43-9006) Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Overall Study STARTED	51
Overall Study Eligible	38
Overall Study Eligible and Began Protocol Therapy	37
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib (BAY 43-9006) Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Overall Study Adverse Event	2
Overall Study Progression	31
Overall Study Not Protocol Specified	4
Overall Study Ineligible	13
Overall Study Never received treatment	1

Baseline Characteristics

S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib (BAY 43-9006) n=37 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Age, Continuous	62.7 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized White	33 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	1 participants n=5 Participants
Histology Leiomyosarcoma	19 participants n=5 Participants
Histology Liposarcoma	10 participants n=5 Participants
Histology Soft Tissue Sarcoma of Vascular Derivation	8 participants n=5 Participants
Performance Status 0	15 participants n=5 Participants
Performance Status 1	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessment performed every eight weeks until progression.

Population: Eligible patients who had received any treatment were included in this analysis.

Outcome measures

Outcome measures
Measure	Leiomyosarcoma n=19 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Liposarcoma n=10 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Vascular Sarcomas n=8 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Total Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Objective Response (Confirmed, Complete and Partial) Unconfirmed PR	1 participants	0 participants	1 participants	—
Objective Response (Confirmed, Complete and Partial) Stable disease/no response	8 participants	2 participants	5 participants	—
Objective Response (Confirmed, Complete and Partial) Progressive disease	9 participants	6 participants	1 participants	—
Objective Response (Confirmed, Complete and Partial) Assessment inadequate	1 participants	2 participants	1 participants	—

SECONDARY outcome

Timeframe: 0 - 4 months

Population: Eligible patients who had received any treatment were included in this analysis.

Outcome measures

Outcome measures
Measure	Leiomyosarcoma n=19 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Liposarcoma n=10 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Vascular Sarcomas n=8 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Total n=37 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Four-month Progression-free Survival Rate	42 percentage of participants Interval 20.0 to 64.0	30 percentage of participants Interval 2.0 to 58.0	63 percentage of participants Interval 29.0 to 96.0	43 percentage of participants Interval 27.0 to 59.0

SECONDARY outcome

Timeframe: Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration 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 were deemed to be related to protocol treatment are included.

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Leiomyosarcoma n=37 Participants Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Liposarcoma Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Vascular Sarcomas Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.	Total Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug ALT, SGPT (serum glutamic pyruvic transaminase)	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug AST, SGOT	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Alkaline phosphatase	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Amylase	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Bilirubin (hyperbilirubinemia)	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Constipation	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Diarrhea	4 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	2 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemoglobin	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypertension	2 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lipase	6 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Nausea	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Abdomen NOS	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pancreatitis	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Platelets	1 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Potassium, serum-low (hypokalemia)	2 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash/desquamation	2 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash: hand-foot skin reaction	4 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Sodium, serum-low (hyponatremia)	2 Participants	—	—	—
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Vomiting	1 Participants	—	—	—

Adverse Events

Sorafenib (BAY 43-9006)

Serious events: 10 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib (BAY 43-9006) n=37 participants at risk Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Blood and lymphatic system disorders Hemoglobin	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Constipation	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Hemorrhage, GI - Colon	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Nausea	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Pain - Abdomen NOS	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Pancreatitis	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
General disorders Pain - Chest/thorax NOS	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations AST, SGOT	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Amylase	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Lipase	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Platelets	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Anorexia	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Nervous system disorders Mental status	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Nervous system disorders Neuropathy: motor	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Nervous system disorders Syncope (fainting)	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Renal and urinary disorders Obstruction, GU - Ureter	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Vascular disorders Hypotension	2.7% 1/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.

Other adverse events

Other adverse events
Measure	Sorafenib (BAY 43-9006) n=37 participants at risk Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Blood and lymphatic system disorders Blood/Bone Marrow-Other (Specify)	16.2% 6/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Blood and lymphatic system disorders Hemoglobin	21.6% 8/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Constipation	35.1% 13/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Diarrhea	51.4% 19/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Flatulence	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Heartburn/dyspepsia	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	16.2% 6/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Nausea	37.8% 14/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Pain - Abdomen NOS	21.6% 8/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Pain - Oral cavity	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Gastrointestinal disorders Vomiting	21.6% 8/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
General disorders Edema: limb	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
General disorders Fatigue (asthenia, lethargy, malaise)	62.2% 23/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Immune system disorders Allergic reaction/hypersensitivity	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Infections and infestations Infection-Other (Specify)	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	21.6% 8/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations AST, SGOT	35.1% 13/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Alkaline phosphatase	29.7% 11/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Amylase	18.9% 7/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Bilirubin (hyperbilirubinemia)	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Creatinine	18.9% 7/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Leukocytes (total WBC)	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Lipase	24.3% 9/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Lymphopenia	16.2% 6/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Metabolic/Laboratory-Other (Specify)	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations PTT (Partial thromboplastin time)	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Platelets	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Investigations Weight loss	27.0% 10/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	35.1% 13/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Anorexia	40.5% 15/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	16.2% 6/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	16.2% 6/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	27.0% 10/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Musculoskeletal and connective tissue disorders Pain - Back	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Musculoskeletal and connective tissue disorders Pain - Bone	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	13.5% 5/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Musculoskeletal and connective tissue disorders Pain - Joint	18.9% 7/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Musculoskeletal and connective tissue disorders Pain - Muscle	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Nervous system disorders Neuropathy: sensory	13.5% 5/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Nervous system disorders Pain - Head/headache	13.5% 5/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Nervous system disorders Taste alteration (dysgeusia)	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Psychiatric disorders Insomnia	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Psychiatric disorders Mood alteration - anxiety	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Renal and urinary disorders Renal/Genitourinary-Other (Specify)	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Renal and urinary disorders Urinary frequency/urgency	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Respiratory, thoracic and mediastinal disorders Cough	16.2% 6/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	5.4% 2/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other (Specify)	8.1% 3/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Dry skin	18.9% 7/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	37.8% 14/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Pain - Scalp	13.5% 5/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Pruritus/itching	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Rash/desquamation	37.8% 14/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	56.8% 21/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Vascular disorders Flushing	10.8% 4/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Vascular disorders Hypertension	32.4% 12/37 • Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.

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