Trial Outcomes & Findings for Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer (NCT NCT00857246)

Last Updated: 2015-12-07

Results Overview

Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

4 months from the beginning of the induction regimen

Results posted on

2015-12-07

Participant Flow

From October 2005 to November 2010, 30 patients were enrolled to the study from New York University Langone Medical Center and its affiliated hospitals.

Participant milestones

Participant milestones
Measure	Induction/ Surgery/ chemoRT 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Induction Regimen STARTED	30
Induction Regimen COMPLETED	27
Induction Regimen NOT COMPLETED	3
Surgery (Curative) STARTED	27
Surgery (Curative) COMPLETED	21
Surgery (Curative) NOT COMPLETED	6
ChemoRT STARTED	15
ChemoRT COMPLETED	12
ChemoRT NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction/ Surgery/ chemoRT 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Induction Regimen Adverse Event	1
Induction Regimen disease-related complications	1
Induction Regimen Withdrawal by Subject	1
Surgery (Curative) disease progression	6
ChemoRT Withdrawal by Subject	1
ChemoRT Adverse Event	2

Baseline Characteristics

Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction/ Surgery/ chemoRT n=30 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (3-4 weeks after induction treatment). 3. Chemoradiation treatment (4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Age, Customized 25-34 years	1 participants n=93 Participants
Age, Customized 35-44 years	1 participants n=93 Participants
Age, Customized 45-53 years	8 participants n=93 Participants
Age, Customized 54-63 years	12 participants n=93 Participants
Age, Customized 64-73 years	3 participants n=93 Participants
Age, Customized 74-83 years	5 participants n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	13 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants

PRIMARY outcome

Timeframe: 4 months from the beginning of the induction regimen

Population: Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=25 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab	40 percentage of paticipants

SECONDARY outcome

Timeframe: 4 months from the beginning of the induction treatment

Population: Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)

This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=25 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy	0 percentage of participants

SECONDARY outcome

Timeframe: 4 months from the beginning of the induction treatment

Population: patients who underwent surgery

This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=27 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Rate of Potentially Curative Surgery	78 percentage of participants

SECONDARY outcome

Timeframe: 4 months from the beginning of the induction treatment

Population: Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)

This is defined as the percentage of patients who had a reduction from T3/T4 disease.

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=25 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Rate of "Down-staging" From Pre-operative Clinical Staging	53 percentage of participants

SECONDARY outcome

Timeframe: 4 months from the beginning of the induction

Population: Patients who had at least a dose of treatment

This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=30 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Safety of the Induction Regimen Neutrophils/granulocytes	13 participants
Safety of the Induction Regimen Diarrhea	4 participants
Safety of the Induction Regimen Fatigue	3 participants
Safety of the Induction Regimen Rash	3 participants
Safety of the Induction Regimen Leukocytes	2 participants
Safety of the Induction Regimen Hypomagnesmia	2 participants
Safety of the Induction Regimen Hypotension	2 participants
Safety of the Induction Regimen Lymphopenia	1 participants
Safety of the Induction Regimen Vomiting	1 participants
Safety of the Induction Regimen Dehydration	1 participants
Safety of the Induction Regimen Hypophosphatemia	1 participants
Safety of the Induction Regimen Hypokelemia	1 participants
Safety of the Induction Regimen Stomatitis/Pharyngitis	1 participants
Safety of the Induction Regimen Febrile neutropenia	1 participants
Safety of the Induction Regimen Hemoglobin	1 participants
Safety of the Induction Regimen Carpopedal syndrome	1 participants

SECONDARY outcome

Timeframe: up to 5 years

Population: Patients who completed induction treatment and underwent curative surgery

This is the length of time from the start of treatment that half of the patients are still alive.

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=21 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Median Overall Survival (Induction Treatment and Curative Surgery)	35.3 months Interval 1.0 to 81.0

SECONDARY outcome

Timeframe: up to 5 years

Population: Patients who received at least one cycle of adjuvant therapy

This is the length of time from the start of treatment that half of the patients are still alive.

Outcome measures

Outcome measures
Measure	Induction/ Surgery/ chemoRT n=15 Participants 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Median Overall Survival (Adjuvant Therpary)	39.5 months Interval 8.0 to 81.0

Adverse Events

Induction/ Surgery/ chemoRT

Serious events: 15 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Induction/ Surgery/ chemoRT n=30 participants at risk 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Gastrointestinal disorders Ascites (non-malignant)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Chest pain (non-cardiac and non-pleuritic)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Dehydration	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Diarrhea patients without colostomy	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (painful swallowing)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Fatigue (lethargy, malaise, asthenia)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Fever (in the absence of neutropenia)	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Abdominal pain or cramping	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Gastrointestinal-Other: small bowel obstruction	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Hematemesis	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Hemoglobin	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Hypotension	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Infections and infestations Infection without neutropenia	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Musculoskeletal-Other: muscle twitching	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Syndromes-Other: carpopedal	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Vascular disorders Thrombosis/embolism	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Vomiting	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.

Other adverse events

Other adverse events
Measure	Induction/ Surgery/ chemoRT n=30 participants at risk 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Gastrointestinal disorders Abdominal pain or cramping	46.7% 14/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Investigations Alkaline phosphatase	30.0% 9/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Alopecia	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Anorexia	63.3% 19/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Arthtitis	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Bicarbonate	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Hepatobiliary disorders Bilirubin	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Cardiovascular/Arrhythmia-Other: Atrial Fibrillation	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Chest pain (non-cardiac and nonpleuritic	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Constipation	40.0% 12/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Investigations Creatitine	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Dehydration	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other: blister	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other: fissurs	16.7% 5/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other: Itchy scalp	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other: Paronychia	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other: surgical scar stiffness	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Diarrhea patients without colostomy	66.7% 20/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Nervous system disorders Dizziness/lightheadedness	23.3% 7/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Eye disorders Dry eye	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Dry skin	23.3% 7/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Dyspepsia/heartburn	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (painful swallowing)	20.0% 6/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	16.7% 5/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Edema	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Fatigue (lethargy, malaise, asthenia)	66.7% 20/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Febrile neutropenia	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Fever (in the absence of neutropenia)	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Flatulence	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Vascular disorders Flushing	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Gastritis	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Gastrointestinal-Other: Abdominal bloating	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Gastrointestinal-Other: Early Satiety	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Gastrointestinal-Other: Hemorrhoids	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Gastrointestinal-Other: Oral Lesions	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Gastrointestinal-Other: Pressure discomfort	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Hand-foot skin reaction	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Nervous system disorders Headache	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Hemoglobin	46.7% 14/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hyperglycemia	36.7% 11/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hyperkalemia	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypermagnesemia	16.7% 5/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypernatremia	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Hypertension	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Hepatobiliary disorders Hypoalbuminemia	23.3% 7/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypocalcemia	26.7% 8/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypoglycemia	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypokalemia	33.3% 10/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypomagnesmia	23.3% 7/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hyponatremia	20.0% 6/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Metabolism and nutrition disorders Hypophosphatemia	16.7% 5/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Hypotension	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Infections and infestations Infection without neutropenia	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Nervous system disorders Insomnia	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Leukocytes (total WBC)	46.7% 14/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Lymphopenia	33.3% 10/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Nervous system disorders Mood alteration-depression	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Mouth dryness	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Nail changes	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Nausea	80.0% 24/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Nervous system disorders Neuropathy-sensory	10.0% 3/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	70.0% 21/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Eye disorders Ocular/Visual - Other: periorbital edema	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Pain-Other: back pain	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Pain-Other: cramps	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Pain-Other: heels	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Injury, poisoning and procedural complications Pain-other: incision site	16.7% 5/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Musculoskeletal and connective tissue disorders Pain-other: thigh pain	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Pain-Other: toungue	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Palpitations	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Blood and lymphatic system disorders Platelets	43.3% 13/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other: sputum	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Radiation dermatitis	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Rash/dermatitis associated with high-dose chemotherapy or BMT studies.	23.3% 7/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Rash/desquamation	80.0% 24/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Rigors, chills	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Hepatobiliary disorders SGOT (AST) (serum glutamic oxaloacetic transaminase)	20.0% 6/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Hepatobiliary disorders SGPT (ALT) (serum glutamic pyruvic transaminase)	23.3% 7/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Cardiac disorders Sinus Tachycardia	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	20.0% 6/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Sweating (diaphoresis)	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Taste disturbance (dysgeusia)	13.3% 4/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Vascular disorders Thrombosis/embolism	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Eye disorders Vision-blurred vision	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Respiratory, thoracic and mediastinal disorders Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)	6.7% 2/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Gastrointestinal disorders Vomiting	40.0% 12/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Weight gain	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
General disorders Weight loss	53.3% 16/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.
Skin and subcutaneous tissue disorders Wound-infectious	3.3% 1/30 • Up to 1 year All the adverse events (AEs) from the induction to adjuvant therapies are reported here regardless of attributions.

Additional Information

Theresa Ryan, MD

Perlmutter Cancer Center

Phone: 212-731-5430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place