Trial Outcomes & Findings for S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer (NCT NCT01498289)

Last Updated: 2019-11-07

Results Overview

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

213 participants

Primary outcome timeframe

Up to 3 years after registration

Results posted on

2019-11-07

Participant Flow

213 participants were randomized, but six were ineligible and 5 were excluded from analysis due to death or withdrawal prior to randomization. Therefore 202 were deemed eligible and analyzable for the primary analysis.

Participant milestones

Participant milestones
Measure	Arm I FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Overall Study STARTED	98	104
Overall Study Participants Assessed for AEs	91	98
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	98	104

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Overall Study Adverse Event	16	18
Overall Study Death	6	8
Overall Study Withdrawal unrelated to AE	16	16
Overall Study Progression/relapse	53	59
Overall Study Not protocol specified	7	2
Overall Study Reason under review	0	1

Baseline Characteristics

S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=98 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II n=104 Participants Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.	Total n=202 Participants Total of all reporting groups
Age, Continuous	62.5 years n=93 Participants	62.4 years n=4 Participants	62.5 years n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	21 Participants n=4 Participants	41 Participants n=27 Participants
Sex: Female, Male Male	78 Participants n=93 Participants	83 Participants n=4 Participants	161 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	19 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=93 Participants	83 Participants n=4 Participants	166 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	83 Participants n=93 Participants	80 Participants n=4 Participants	163 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	10 Participants n=4 Participants	12 Participants n=27 Participants
ERCC1 High (>=1.7)	13 Participants n=93 Participants	15 Participants n=4 Participants	28 Participants n=27 Participants
ERCC1 Low (<1.7)	85 Participants n=93 Participants	89 Participants n=4 Participants	174 Participants n=27 Participants
Site of Disease Esophageal	33 Participants n=93 Participants	36 Participants n=4 Participants	69 Participants n=27 Participants
Site of Disease Gastric/GEJ	65 Participants n=93 Participants	68 Participants n=4 Participants	133 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 3 years after registration

Population: Eligible and analyzable participants with ERCC1 level \>= 1.7

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Arm I FOLFOX n=13 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT n=15 Participants IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Progression-free Survival (PFS) in High-ERCC1 Patients	4.7 months Interval 2.1 to 8.7	5.3 months Interval 0.9 to 11.5

PRIMARY outcome

Timeframe: Up to 3 years after registration

Population: Eligible and analyzable participants with ERCC1 level \< 1.7

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Arm I FOLFOX n=85 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT n=89 Participants IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
PFS in Low-ERCC1 Participants	5.9 months Interval 4.1 to 7.1	2.8 months Interval 1.7 to 4.1

PRIMARY outcome

Timeframe: Up to 3 years after registration

Population: Eligible and analyzable participants

OS is the length of time between protocol registration and patient death

Outcome measures

Outcome measures
Measure	Arm I FOLFOX n=98 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT n=104 Participants IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Overall Survival (OS)	11.4 months Interval 9.8 to 13.5	8.7 months Interval 6.0 to 10.1

SECONDARY outcome

Timeframe: Up to 3 years after registration

Population: Participants with measurable disease

ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm I FOLFOX n=79 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT n=88 Participants IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Overall Response Rate (ORR)	42 percentage of evaluable participants Interval 31.0 to 53.0	30 percentage of evaluable participants Interval 20.0 to 39.0

SECONDARY outcome

Timeframe: up to 3 years after registration

Population: Eligible and analyzable participants were divided into quartiles based on ERCC1 levels.

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first. Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.

Outcome measures

Outcome measures
Measure	Arm I FOLFOX n=98 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT n=104 Participants IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
PFS Variation by ERCC1 Q1 ERCC1 (0.20-0.80)	5.6 months Interval 2.4 to 8.3	2.8 months Interval 1.4 to 4.9
PFS Variation by ERCC1 Q2 ERCC1 (0.81-1.10)	7.4 months Interval 4.1 to 9.1	3.0 months Interval 1.9 to 4.2
PFS Variation by ERCC1 Q3 ERCC1 (1.11-1.42)	5.6 months Interval 2.9 to 7.0	2.9 months Interval 1.0 to 4.7
PFS Variation by ERCC1 Q4 ERCC1 (1.43-5.71)	4.6 months Interval 2.1 to 8.7	2.6 months Interval 1.3 to 5.6

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 3 years post registration

Population: Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Arm I FOLFOX n=91 Participants FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium. fluorouracil: 400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.	Arm II IT n=98 Participants IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypokalemia	2 Participants	8 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Abdominal pain	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Activated partial thromboplastin time prolonged	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Acute kidney injury	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alanine aminotransferase increased	2 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alkaline phosphatase increased	1 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Allergic reaction	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	6 Participants	14 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	0 Participants	7 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	2 Participants	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Back pain	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bladder infection	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Blood bilirubin increased	1 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bone pain	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs CD4 lymphocytes decreased	0 Participants	3 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Confusion	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Death NOS	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	2 Participants	19 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Depression	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	4 Participants	28 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dry mouth	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dysphagia	1 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Edema limbs	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Esophageal hemorrhage	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Esophagitis	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	7 Participants	14 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	1 Participants	6 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Gastrointestinal pain	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	2 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Headache	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Heart failure	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyperglycemia	1 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypertension	1 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoalbuminemia	1 Participants	4 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypocalcemia	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypomagnesemia	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	2 Participants	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypotension	1 Participants	3 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs INR increased	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infections and infestations - Other, specify	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infusion related reaction	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Leukocytosis	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	1 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	9 Participants	7 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis oral	2 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Multi-organ failure	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	7 Participants	12 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	29 Participants	19 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Non-cardiac chest pain	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Obstruction gastric	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Palmar-plantar erythrodysesthesia syndrome	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Peripheral motor neuropathy	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Peripheral sensory neuropathy	10 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Platelet count decreased	5 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pneumonitis	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Respiratory failure	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sepsis	1 Participants	6 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Stomach pain	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Syncope	1 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Thromboembolic event	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Upper gastrointestinal hemorrhage	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Urinary tract infection	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vascular access complication	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vomiting	5 Participants	8 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Weight loss	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	9 Participants	14 Participants

Adverse Events

Arm I FOLFOX

Serious events: 7 serious events

Other events: 88 other events

Deaths: 89 deaths

Arm II IT

Serious events: 17 serious events

Other events: 95 other events

Deaths: 94 deaths

Serious adverse events

Other adverse events

Additional Information

SWOG Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm I FOLFOX n=91 participants at risk FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium.	Arm II IT n=98 participants at risk IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
Gastrointestinal disorders Diarrhea	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	1.0% 1/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Gastrointestinal disorders Mucositis oral	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	0.00% 0/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
General disorders Death NOS	2.2% 2/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	4.1% 4/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
General disorders Multi-organ failure	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	2.0% 2/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
General disorders Sudden death NOS	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	0.00% 0/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Infections and infestations Lung infection	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	0.00% 0/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Infections and infestations Sepsis	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	6.1% 6/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Investigations Alanine aminotransferase increased	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	0.00% 0/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Investigations Aspartate aminotransferase increased	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	0.00% 0/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Investigations Neutrophil count decreased	1.1% 1/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	0.00% 0/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Investigations White blood cell decreased	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	1.0% 1/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Metabolism and nutrition disorders Dehydration	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	1.0% 1/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	5.1% 5/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	2.0% 2/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Vascular disorders Hypotension	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	1.0% 1/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
Vascular disorders Thromboembolic event	0.00% 0/91 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs	1.0% 1/98 • Duration of treatment and follow up until death or 3 years post registration Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs