Trial Outcomes & Findings for Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer (NCT NCT00514020)
NCT ID: NCT00514020
Last Updated: 2012-11-01
Results Overview
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
every 8 weeks to progression
Results posted on
2012-11-01
Participant Flow
This study was conducted from August 2007 to March 2011.
Forty-two patients signed consent, 9 of which were found to be ineligible to participate in the study.
Participant milestones
| Measure |
5-FU, Leucovorin, Oxaliplatin
Patients who have TSER\*2/\*2 or TSER\*2/\*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER\*3 will not be included in study.
* FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.
* Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
5-FU, Leucovorin, Oxaliplatin
Patients who have TSER\*2/\*2 or TSER\*2/\*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER\*3 will not be included in study.
* FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.
* Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
disease progression
|
9
|
|
Overall Study
other complicating disease
|
2
|
|
Overall Study
patient went to radiation treatment
|
1
|
|
Overall Study
patients moved to the "no tx" group
|
6
|
Baseline Characteristics
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin + Leucovorin + 5-Fluorouracil
n=33 Participants
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
58 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 8 weeks to progressionPopulation: Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous "good risk" genotype group. One patient was not evaluable for response.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.
Outcome measures
| Measure |
Oxaliplatin + Leucovorin + 5-Fluorouracil
n=24 Participants
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Complete Response
|
0 participants
|
|
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Partial Response
|
9 participants
|
|
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Progressive Disease
|
1 participants
|
|
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Stable Disease
|
14 participants
|
Adverse Events
Oxaliplatin + Leucovorin + 5-Fluorouracil
Serious events: 14 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin + Leucovorin + 5-Fluorouracil
n=24 participants at risk
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Gastrointestinal disorders
constipation
|
12.5%
3/24 • Number of events 6
|
|
Gastrointestinal disorders
distension/bloating, abdominal
|
4.2%
1/24 • Number of events 2
|
|
Gastrointestinal disorders
dysphagia
|
12.5%
3/24 • Number of events 6
|
|
General disorders
fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L)
|
4.2%
1/24 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
16.7%
4/24 • Number of events 6
|
|
Renal and urinary disorders
obstruction, GU-ureter
|
4.2%
1/24 • Number of events 2
|
|
Gastrointestinal disorders
pain-abdomen NOS
|
25.0%
6/24 • Number of events 10
|
|
Renal and urinary disorders
urinary retention
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
12.5%
3/24 • Number of events 4
|
|
Blood and lymphatic system disorders
INR (international normalized ratio of prothrombin)
|
4.2%
1/24 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.2%
1/24 • Number of events 1
|
|
General disorders
death not associated with CTCAE-disease progression NOS
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
infection with normal ANC or Grade 1 or 2 neutrophils-skin (cellulitis)
|
4.2%
1/24 • Number of events 2
|
|
Cardiac disorders
supraventricular and nodal arrhythmia-atrial fibrillation
|
8.3%
2/24 • Number of events 3
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Oxaliplatin + Leucovorin + 5-Fluorouracil
n=24 participants at risk
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Metabolism and nutrition disorders
albumin, serum-low
|
70.8%
17/24 • Number of events 29
|
|
Investigations
alkaline phosphatase
|
41.7%
10/24 • Number of events 13
|
|
Investigations
ALT/SGPT (serum glutamine pyruvic transminase)
|
45.8%
11/24 • Number of events 15
|
|
Metabolism and nutrition disorders
anorexia
|
33.3%
8/24 • Number of events 8
|
|
Gastrointestinal disorders
ascites (non-malignant)
|
12.5%
3/24 • Number of events 4
|
|
Investigations
AST, SGOT (serum glutamine oxaloacetic transminase)
|
45.8%
11/24 • Number of events 13
|
|
Hepatobiliary disorders
bilirubin (hyperbilirubinemia)
|
8.3%
2/24 • Number of events 3
|
|
Metabolism and nutrition disorders
calcium, serum-low-hypocalcemia
|
41.7%
10/24 • Number of events 14
|
|
Gastrointestinal disorders
constipation
|
29.2%
7/24 • Number of events 11
|
|
Investigations
creatine
|
8.3%
2/24 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
dermatology/skin-other
|
8.3%
2/24 • Number of events 3
|
|
Gastrointestinal disorders
diarrhea
|
33.3%
8/24 • Number of events 14
|
|
Gastrointestinal disorders
distension/bloating, abdominal
|
25.0%
6/24 • Number of events 6
|
|
Nervous system disorders
dizziness
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
dysphagia
|
12.5%
3/24 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
edema-limb
|
12.5%
3/24 • Number of events 3
|
|
General disorders
fatigue
|
50.0%
12/24 • Number of events 17
|
|
Metabolism and nutrition disorders
glucose, serum-high-hyperglycemia
|
45.8%
11/24 • Number of events 21
|
|
Gastrointestinal disorders
heartburn/dyspepsia
|
8.3%
2/24 • Number of events 2
|
|
Investigations
hemoglobin
|
91.7%
22/24 • Number of events 33
|
|
Psychiatric disorders
insomnia
|
12.5%
3/24 • Number of events 4
|
|
Blood and lymphatic system disorders
leukocytes (total WBC)
|
58.3%
14/24 • Number of events 32
|
|
Blood and lymphatic system disorders
lymphopenia
|
37.5%
9/24 • Number of events 19
|
|
Investigations
metabolic/laboratory-other
|
8.3%
2/24 • Number of events 2
|
|
Psychiatric disorders
mood alteration-anxiety
|
8.3%
2/24 • Number of events 2
|
|
Psychiatric disorders
mood alteration-depression
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
mucositis/stomatitis (clinical exam)-oral cavity
|
16.7%
4/24 • Number of events 6
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)-oral cavity
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
62.5%
15/24 • Number of events 22
|
|
Nervous system disorders
neuropathy - sensory
|
58.3%
14/24 • Number of events 39
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
12/24 • Number of events 40
|
|
Gastrointestinal disorders
pain-abdomen NOS
|
33.3%
8/24 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Pain-extremity-limb
|
8.3%
2/24 • Number of events 2
|
|
General disorders
pain-other
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
platelets
|
58.3%
14/24 • Number of events 32
|
|
Metabolism and nutrition disorders
potassium, serum-low (hypokalemia)
|
25.0%
6/24 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
rash-hand-foot skin reaction
|
8.3%
2/24 • Number of events 2
|
|
Metabolism and nutrition disorders
sodium, serum-low (hyponatremia)
|
16.7%
4/24 • Number of events 8
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
33.3%
8/24 • Number of events 8
|
|
Eye disorders
vision/blurred vision
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
vomiting
|
29.2%
7/24 • Number of events 11
|
|
Investigations
weight loss
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
fever in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 12e9/L
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
infection with normal ANC or Grade 1 or 2 neutrophils-abdomen NOS
|
8.3%
2/24 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place