Trial Outcomes & Findings for Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction (NCT NCT00062374)

Last Updated: 2017-07-06

Results Overview

The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis. Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated Non-Responder= Tumor Regression Grade 3 or higher Responder=Tumor Regression Grade 1 (CR) or Grade 2 (PR)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Day 15

Results posted on

2017-07-06

Participant Flow

Date Opened to Accrual: 6/5/2003 Date Closed to Accrual: 8/8/2006 Date Closed: 6/28/2011 Recruitment location is the medical clinic

Participant milestones

Participant milestones
Measure	Arm I Cisplatin + Irinotecan
Overall Study STARTED	55
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Cisplatin + Irinotecan
Overall Study Not treated	12

Baseline Characteristics

Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=55 Participants Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. irinotecan hydrochloride: Given IV cisplatin: Given IV conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection positron emission tomography/computed tomography: Undergo FDG-PET/CT fludeoxyglucose F 18: Undergo FDG-PET/CT positron emission tomography/computed tomography: Undergo FLT-PET/CT fluorine F 18 fluorothymidine: Undergo FLT-PET/CT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Technical problems with measurement of FDG-SUV data leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only histological response is reported.

Outcome measures

Outcome measures
Measure	Arm I n=43 Participants Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. irinotecan hydrochloride: Given IV cisplatin: Given IV conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection positron emission tomography/computed tomography: Undergo FDG-PET/CT fludeoxyglucose F 18: Undergo FDG-PET/CT positron emission tomography/computed tomography: Undergo FLT-PET/CT fluorine F 18 fluorothymidine: Undergo FLT-PET/CT
Histological Response Determined by FDG Uptake Correlates Progression of Disease	2 participants
Histological Response Determined by FDG Uptake Correlates Responders	3 participants
Histological Response Determined by FDG Uptake Correlates Non-Responders	38 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years

Population: Technical problems with measurement leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated.

Overall Survival (OS) and Disease Free Survival (DFS) are the secondary endpoints. Technical problems with measurement of OS leading to unreliable or uniterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only DFS data is being reported.

Outcome measures

Outcome measures
Measure	Arm I n=43 Participants Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. irinotecan hydrochloride: Given IV cisplatin: Given IV conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection positron emission tomography/computed tomography: Undergo FDG-PET/CT fludeoxyglucose F 18: Undergo FDG-PET/CT positron emission tomography/computed tomography: Undergo FLT-PET/CT fluorine F 18 fluorothymidine: Undergo FLT-PET/CT
Disease Free Survival (DFS)	23.8 months Interval 14.0 to The value is infinity.

Adverse Events

Arm I

Serious events: 14 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=55 participants at risk Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. irinotecan hydrochloride: Given IV cisplatin: Given IV conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection positron emission tomography/computed tomography: Undergo FDG-PET/CT fludeoxyglucose F 18: Undergo FDG-PET/CT positron emission tomography/computed tomography: Undergo FLT-PET/CT fluorine F 18 fluorothymidine: Undergo FLT-PET/CT
Gastrointestinal disorders Abdominal pain/cramping	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Nervous system disorders CNS/cerebrovascular ischemia	3.6% 2/55 • Number of events 2 Number of participants at risk is the same as the total number of participants that were treated.
Cardiac disorders Cardiovascular, other	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
General disorders Chest pain	3.6% 2/55 • Number of events 2 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Creatinine increased	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Dehydration	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Diarrhea	3.6% 2/55 • Number of events 2 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Fatigue	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Blood and lymphatic system disorders Febrile neutropenia	5.5% 3/55 • Number of events 3 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Gastrointestinal disorder	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Blood and lymphatic system disorders Hemorrhage, NOS	3.6% 2/55 • Number of events 3 Number of participants at risk is the same as the total number of participants that were treated.
Blood and lymphatic system disorders Hemoglobin decrease	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hyperglycemia	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Vascular disorders Hypotension	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Musculoskeletal and connective tissue disorders Muscle weakness	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Nausea	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Neutrophil count decrease	3.6% 2/55 • Number of events 2 Number of participants at risk is the same as the total number of participants that were treated.
Nervous system disorders Seizure	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.
Vascular disorders Thrombosis	9.1% 5/55 • Number of events 6 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Vomiting	1.8% 1/55 • Number of events 1 Number of participants at risk is the same as the total number of participants that were treated.

Other adverse events

Other adverse events
Measure	Arm I n=55 participants at risk Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. irinotecan hydrochloride: Given IV cisplatin: Given IV conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection positron emission tomography/computed tomography: Undergo FDG-PET/CT fludeoxyglucose F 18: Undergo FDG-PET/CT positron emission tomography/computed tomography: Undergo FLT-PET/CT fluorine F 18 fluorothymidine: Undergo FLT-PET/CT
Gastrointestinal disorders Abdominal pain/cramping	27.3% 15/55 • Number of events 24 Number of participants at risk is the same as the total number of participants that were treated.
Skin and subcutaneous tissue disorders Alopecia	9.1% 5/55 • Number of events 6 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Anorexia	29.1% 16/55 • Number of events 18 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Constipation	7.3% 4/55 • Number of events 5 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Creatinine	10.9% 6/55 • Number of events 43 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Dehydration	10.9% 6/55 • Number of events 8 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Diarrhea	45.5% 25/55 • Number of events 41 Number of participants at risk is the same as the total number of participants that were treated.
Nervous system disorders Dizziness	10.9% 6/55 • Number of events 7 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Dyspepsia	7.3% 4/55 • Number of events 4 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Dysphagia	5.5% 3/55 • Number of events 3 Number of participants at risk is the same as the total number of participants that were treated.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.7% 7/55 • Number of events 7 Number of participants at risk is the same as the total number of participants that were treated.
General disorders Edema	10.9% 6/55 • Number of events 6 Number of participants at risk is the same as the total number of participants that were treated.
General disorders Fatigue	65.5% 36/55 • Number of events 83 Number of participants at risk is the same as the total number of participants that were treated.
Blood and lymphatic system disorders Hemoglobin decrease	54.5% 30/55 • Number of events 54 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hyperglycemia	20.0% 11/55 • Number of events 20 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hyperkalemia	20.0% 11/55 • Number of events 12 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypernatremia	9.1% 5/55 • Number of events 5 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 11/55 • Number of events 27 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypocalcemia	63.6% 35/55 • Number of events 219 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypoglycemia	5.5% 3/55 • Number of events 3 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypokalemia	29.1% 16/55 • Number of events 31 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypomagnesemia	21.8% 12/55 • Number of events 41 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hyponatremia	36.4% 20/55 • Number of events 60 Number of participants at risk is the same as the total number of participants that were treated.
Metabolism and nutrition disorders Hypophosphatemia	30.9% 17/55 • Number of events 31 Number of participants at risk is the same as the total number of participants that were treated.
Ear and labyrinth disorders Hearing impaired	7.3% 4/55 • Number of events 4 Number of participants at risk is the same as the total number of participants that were treated.
Investigations White blood cell count decrease	58.2% 32/55 • Number of events 148 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Lymphocyte count decrease	20.0% 11/55 • Number of events 37 Number of participants at risk is the same as the total number of participants that were treated.
Psychiatric disorders Mood alteration/anxiety	7.3% 4/55 • Number of events 5 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Nausea	60.0% 33/55 • Number of events 64 Number of participants at risk is the same as the total number of participants that were treated.
Nervous system disorders Neuropathy-sensory	20.0% 11/55 • Number of events 12 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Neutrophil count decrease	56.4% 31/55 • Number of events 112 Number of participants at risk is the same as the total number of participants that were treated.
General disorders Pain, other	5.5% 3/55 • Number of events 3 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Platelet count decreased	38.2% 21/55 • Number of events 81 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Aspartate aminotransferase increase	12.7% 7/55 • Number of events 14 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Alanine aminotransferase increase	18.2% 10/55 • Number of events 31 Number of participants at risk is the same as the total number of participants that were treated.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	5.5% 3/55 • Number of events 4 Number of participants at risk is the same as the total number of participants that were treated.
Nervous system disorders Taste disturbance	7.3% 4/55 • Number of events 6 Number of participants at risk is the same as the total number of participants that were treated.
Vascular disorders Thrombosis	9.1% 5/55 • Number of events 5 Number of participants at risk is the same as the total number of participants that were treated.
Gastrointestinal disorders Vomiting	21.8% 12/55 • Number of events 23 Number of participants at risk is the same as the total number of participants that were treated.
Investigations Weight loss	9.1% 5/55 • Number of events 6 Number of participants at risk is the same as the total number of participants that were treated.

Additional Information

Dr. David P. Kelsen

Memorial Sloan-Kettering Cancer Center

Phone: 646-888-4179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60