Trial Outcomes & Findings for Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers (NCT NCT00848783)

Last Updated: 2018-01-08

Results Overview

This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 year

Results posted on

2018-01-08

Participant Flow

Between March 2008 and May 2010 eight patient were enrolled to the study from New York University Langone Medical Center and University of South California Cancer Center.

Patients were randomized to Arm A or Arm B after the response evaluation of the induction treatment. One patient was not randomized due to progression of disease before surgery and was taken off the protocol treatment.

Participant milestones

Participant milestones
Measure	A-with IP Floxuridine 1. Induction treatment: Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery. 5. Postoperative IP treatment: Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once 6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral	B-Without IP Floxuridine Same as Arm A except no postoperative IP treatment.	Induction Treartment Only This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
Overall Study STARTED	4	3	1
Overall Study COMPLETED	1	1	1
Overall Study NOT COMPLETED	3	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-with IP Floxuridine n=4 Participants 1. Induction treatment: Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery. 5. Postoperative IP treatment: Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once 6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral	B-Without IP Floxuridine n=3 Participants Same as Arm A except no postoperative IP treatment.	Induction Treatment Only n=1 Participants This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 12.8 • n=5 Participants	54.3 years STANDARD_DEVIATION 3.2 • n=7 Participants	60 years STANDARD_DEVIATION 0 • n=5 Participants	54.8 years STANDARD_DEVIATION 8.8 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	8 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Based on intent-to-treat population.

This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.

Outcome measures

Outcome measures
Measure	A-with IP Floxuridine n=4 Participants 1. Induction treatment: Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery. 5. Postoperative IP treatment: Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once 6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral	B-Without IP Floxuridine n=3 Participants Same as Arm A except no postoperative IP treatment.	Induction Treatment Only This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
Number of Patients With One-year Recurrence-free Survival	3 participants	2 participants	—

SECONDARY outcome

Timeframe: every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years

Population: Secondary outcome measure was not analyzed as study was terminated

Secondary outcome measure was not analyzed as study was terminated

Outcome measures

Outcome data not reported

Adverse Events

A-with IP Floxuridine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

B-Without IP Floxuridine

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A-with IP Floxuridine n=4 participants at risk 1. Induction treatment: Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery. 5. Postoperative IP treatment: Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once 6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral	B-Without IP Floxuridine n=3 participants at risk Same as Arm A except no postoperative IP treatment.
Blood and lymphatic system disorders Neutrophils/Granulocytes (Anc/Agc)	0.00% 0/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Infections and infestations Infection With Normal Anc Or Grade 1 Or 2 Neutrophils	0.00% 0/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.

Other adverse events

Additional Information

Franco Muggia, MD

NYU Cancer Institute

Phone: 212-263-6485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	A-with IP Floxuridine n=4 participants at risk 1. Induction treatment: Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery. 5. Postoperative IP treatment: Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once 6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral	B-Without IP Floxuridine n=3 participants at risk Same as Arm A except no postoperative IP treatment.
Blood and lymphatic system disorders Blood/Bone Marrow - Other (Specify, __)	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Blood and lymphatic system disorders Hemoglobin	100.0% 4/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Cardiac disorders Palpitations	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
General disorders Fatigue (Asthenia, Lethargy, Malaise)	100.0% 4/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
General disorders Insomnia	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
General disorders Weight Loss	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Anorexia	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Constipation	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Diarrhea	100.0% 4/4 • The adverse events were followed during the whole treatment phase, about 1 year.	66.7% 2/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Distension/Bloating, Abdominal	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Dysphagia (Difficulty Swallowing)	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Heartburn/Dyspepsia	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
General disorders Nausea	100.0% 4/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Taste Alteration (Dysgeusia)	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Gastrointestinal disorders Vomiting	75.0% 3/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Investigations Alt, Sgpt (Serum Glutamic Pyruvic Transaminase)	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Investigations Ast, Sgot(Serum Glutamic Oxaloacetic Transaminase)	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Metabolism and nutrition disorders Glucose, Serum-High (Hyperglycemia)	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Nervous system disorders Dizziness	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Nervous system disorders Mood Alteration	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Nervous system disorders Neurology - Other (Specify, __)	50.0% 2/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Nervous system disorders Neuropathy: Sensory	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
General disorders Pain	75.0% 3/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Blood and lymphatic system disorders Neutrophils/Granulocytes (Anc/Agc)	75.0% 3/4 • The adverse events were followed during the whole treatment phase, about 1 year.	33.3% 1/3 • The adverse events were followed during the whole treatment phase, about 1 year.
Blood and lymphatic system disorders Platelets	25.0% 1/4 • The adverse events were followed during the whole treatment phase, about 1 year.	0.00% 0/3 • The adverse events were followed during the whole treatment phase, about 1 year.