Trial Outcomes & Findings for Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer (NCT NCT00454324)

Last Updated: 2017-07-11

Results Overview

Radiological imaging should be performed every 12 weeks, to ascertain the overall (or objective) response rate (Complete Response or Partial Response) according to the RECIST guidelines. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Overall Response Rate = CR+PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-07-11

Participant Flow

30 patients consented to participate in the study. 3 patients were consented but not treated; 2 were found ineligible, and 1 withdrew before treatment.

Participant milestones

Participant milestones
Measure	Arm A Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of Area Under the Curve (AUC)=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Overall Study STARTED	14	13
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=14 Participants Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 Participants Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Total n=27 Participants Total of all reporting groups
Age, Continuous	70 years n=5 Participants	70.4 years n=7 Participants	70 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Arm A n=14 Participants Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 Participants Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Overall Response Rate	79 percentage of participants Interval 49.0 to 95.0	85 percentage of participants Interval 55.0 to 98.0

SECONDARY outcome

Timeframe: every 12 weeks for 1 year

Percentage of participants from the start of treatment with the disease that are still alive.

Outcome measures

Outcome measures
Measure	Arm A n=14 Participants Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 Participants Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
1-year Overall Survival (OS)	36 percentage of participants Interval 13.0 to 59.0	42 percentage of participants Interval 15.0 to 67.0

SECONDARY outcome

Timeframe: Through the end of the study, an average of approximately 8 months

Defined as the time between trial enrollment to disease progression or death (whichever occurs first) or date of last contact

Outcome measures

Outcome measures
Measure	Arm A n=14 Participants Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 Participants Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Progression Free Survival (PFS)	5.8 Months Interval 2.7 to 7.1	5.2 Months Interval 2.9 to 6.7

SECONDARY outcome

Timeframe: 10 weeks

Drug toxicities will be evaluated during treatment period and 30 days post treatment. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) criteria. Grade 3 or 4 adverse events were reported

Outcome measures

Outcome measures
Measure	Arm A n=14 Participants Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 Participants Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Number of Individuals With Adverse Events Diarrhea	1 Participants	1 Participants
Number of Individuals With Adverse Events Neutropenia	8 Participants	5 Participants
Number of Individuals With Adverse Events Anemia	4 Participants	4 Participants
Number of Individuals With Adverse Events Thrombocytopenia	3 Participants	3 Participants
Number of Individuals With Adverse Events Sensory neuropathy	3 Participants	0 Participants
Number of Individuals With Adverse Events Pain	4 Participants	0 Participants
Number of Individuals With Adverse Events Fatigue	0 Participants	1 Participants
Number of Individuals With Adverse Events Nausea	0 Participants	3 Participants
Number of Individuals With Adverse Events Vomiting	0 Participants	2 Participants

Adverse Events

Arm A

Serious events: 7 serious events

Other events: 14 other events

Deaths: 14 deaths

Arm B

Serious events: 4 serious events

Other events: 12 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=14 participants at risk Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 participants at risk Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Nausea	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Investigations Neutrophils/granulocytes (ANC/AGC)	21.4% 3/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Pain - Esophagus	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Muscle	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Vomiting	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Vascular disorders Hypotension	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Psychiatric disorders Confusion	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders hyperglycemia	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Syncope	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Blood and lymphatic system disorders febrile neutropenia	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.

Other adverse events

Additional Information

Robin V. Johnson

UNC Lineberger Comprehensive Cancer Center

Phone: 919-966-1125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Arm A n=14 participants at risk Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)	Arm B n=13 participants at risk Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Skin and subcutaneous tissue disorders Alopecia	21.4% 3/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Anorexia	28.6% 4/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Psychiatric disorders Anxiety	28.6% 4/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Investigations Alkaline phosphatase	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Ataxia (incoordination)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Chest wall pain	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Constipation	21.4% 3/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 4/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Investigations Creatinine	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Dehydration	14.3% 2/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Psychiatric disorders Depression	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Diarrhea	21.4% 3/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Dizziness	14.3% 2/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	14.3% 2/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Edema: limb	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Extremity-lower (gait/walking)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Fatigue (asthenia, lethargy, malaise)	64.3% 9/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	61.5% 8/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Gastritis	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	14.3% 2/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Head/headache	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Blood and lymphatic system disorders Hemoglobin	35.7% 5/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	69.2% 9/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Hemorrhoids	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Vascular disorders Hypertension	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Infections and infestations Infection - Other (Specify, __)	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Injection site reaction/extravasation changes	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Psychiatric disorders Insomnia	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Investigations Leukocytes (total WBC)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	23.1% 3/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Nausea	64.3% 9/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	23.1% 3/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Neuropathy: sensory	57.1% 8/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	53.8% 7/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Blood and lymphatic system disorders Neutropenia	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	57.1% 8/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	69.2% 9/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Pain - Abdomen NOS	21.4% 3/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Back	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Bone	21.4% 3/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Chest wall	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Pain - Chest/thorax NOS	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	23.1% 3/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Eye disorders Pain - Eye	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Pain - Head/headache	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Joint	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Renal and urinary disorders Pain - Kidney	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Musculoskeletal and connective tissue disorders Pain - Muscle	28.6% 4/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Pain - Neuralgia/peripheral nerve	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Pain - Other (Specify, __)	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
General disorders Pain - Pain NOS	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Reproductive system and breast disorders Pain - Pelvis	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Pain - Rectum	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Skin and subcutaneous tissue disorders Pain - Skin	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Pain - Stomach	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Blood and lymphatic system disorders Platelets	57.1% 8/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	46.2% 6/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	14.3% 2/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	15.4% 2/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Skin and subcutaneous tissue disorders Pruritus/itching	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Nervous system disorders Taste alteration (dysgeusia)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Gastrointestinal disorders Vomiting	35.7% 5/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Blood and lymphatic system disorders Lymphatics - Other (Specify)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Metabolic/Laboratory - Other (Specify, __)	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Pancreatic endocrine: glucose intolerance	7.1% 1/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	0.00% 0/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.
Metabolism and nutrition disorders Metabolic/Lab - Other (Specify)	0.00% 0/14 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.	7.7% 1/13 • Patients will be evaluated 30 days (+/- 4 days) after completion of treatment for toxicity.