Trial Outcomes & Findings for Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (NCT NCT00515411)
NCT ID: NCT00515411
Last Updated: 2019-12-10
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Results posted on
2019-12-10
Participant Flow
Participant milestones
| Measure |
Arm A, - Modified DCF
Drug Dose (mg/m2) Schedule
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
|
ARM B - Parent DCF With G-CSF
Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17
\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
|
Arm C - Modified DCF+ Trastuzumab
Treatment for Her2 Positive Participants
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
31
|
26
|
|
Overall Study
COMPLETED
|
54
|
31
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Arm A, - Modified DCF
n=54 Participants
Drug Dose (mg/m2) Schedule
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
|
ARM B - Parent DCF With G-CSF
n=31 Participants
Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17
\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
|
Arm C - Modified DCF+ Trastuzumab
n=26 Participants
Treatment for Her2 Positive Participants
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
|
Total
n=111 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
|
40 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate
Outcome measures
| Measure |
Arm A, - Modified DCF
n=54 Participants
Drug Dose (mg/m2) Schedule
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
|
ARM B - Parent DCF With G-CSF
n=31 Participants
Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17
\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
|
Arm C - Modified DCF+ Trastuzumab
n=26 Participants
Treatment for Her2 Positive Participants
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
|
|---|---|---|---|
|
6 Month Progression Free Survival (PFS)
|
63 percentage of paticipants
Interval 48.0 to 75.0
|
53 percentage of paticipants
Interval 34.0 to 69.0
|
73 percentage of paticipants
Interval 51.0 to 86.0
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 monthsOverall survival measured in months
Outcome measures
| Measure |
Arm A, - Modified DCF
n=54 Participants
Drug Dose (mg/m2) Schedule
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
|
ARM B - Parent DCF With G-CSF
n=31 Participants
Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17
\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
|
Arm C - Modified DCF+ Trastuzumab
n=26 Participants
Treatment for Her2 Positive Participants
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
|
|---|---|---|---|
|
Overall Survival
|
18.8 months
Interval 14.9 to 24.5
|
12.6 months
Interval 6.7 to 16.0
|
24.9 months
Interval 14.4 to 42.5
|
Adverse Events
Arm A, - Modified DCF
Serious events: 26 serious events
Other events: 26 other events
Deaths: 37 deaths
ARM B - Parent DCF With G-CSF
Serious events: 23 serious events
Other events: 23 other events
Deaths: 30 deaths
Arm C - Modified DCF+ Trastuzumab
Serious events: 13 serious events
Other events: 13 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Arm A, - Modified DCF
n=54 participants at risk
Drug Dose (mg/m2) Schedule
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
|
ARM B - Parent DCF With G-CSF
n=31 participants at risk
Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17
\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
|
Arm C - Modified DCF+ Trastuzumab
n=26 participants at risk
Treatment for Her2 Positive Participants
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
|
|---|---|---|---|
|
Immune system disorders
Allerg react/hypersens (incl drug fever)
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.7%
2/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Cardiac disorders
Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Cardiac disorders
Cardiac General, other
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Colitis, infectious
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.6%
3/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Investigations
Creatinine
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
1.9%
1/54 • 2 years
|
12.9%
4/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
5/54 • 2 years
|
22.6%
7/31 • 2 years
|
15.4%
4/26 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
3/54 • 2 years
|
12.9%
4/31 • 2 years
|
19.2%
5/26 • 2 years
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.7%
2/54 • 2 years
|
9.7%
3/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
General disorders
Localized Edema - trunk/genital
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
7.4%
4/54 • 2 years
|
12.9%
4/31 • 2 years
|
19.2%
5/26 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.4%
4/54 • 2 years
|
16.1%
5/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
19.2%
5/26 • 2 years
|
|
Gastrointestinal disorders
Fistula, GI- Small bowel NOS
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
5.6%
3/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Vascular disorders
Hematoma
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
7.4%
4/54 • 2 years
|
6.5%
2/31 • 2 years
|
15.4%
4/26 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Stoma (GI)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Stomach
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Vascular disorders
Hypotension
|
3.7%
2/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Ileus, GI (func obstruction of bowel)
|
5.6%
3/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Catheter-related
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Urinary(bladder)
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Abdomen NOS
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Lung (pneumonia)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Infection, other
|
3.7%
2/54 • 2 years
|
6.5%
2/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Investigations
INR
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Leak, GI- Leak NOS
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Investigations
Leukocytes (total WBC)
|
3.7%
2/54 • 2 years
|
3.2%
1/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Investigations
Lymphopenia
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Investigations
Metabolic/Lab - Other (specify)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
1.9%
1/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Mucositis (func/sympt)- Oral cavity
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Right-sided
|
1.9%
1/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
14.8%
8/54 • 2 years
|
29.0%
9/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
9.3%
5/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Obstruction, GI- Colon
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Obstruction, GI- Small bowel NOS
|
3.7%
2/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Obstruction, GI- Stomach
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
14.8%
8/54 • 2 years
|
19.4%
6/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Cardiac disorders
Pain - Cardiac/heart
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest/thorax NOS
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Pain - Other (specify)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Pain - Stomach
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Perforation, GI- Cecum
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
7.4%
4/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Nervous system disorders
Syncope (fainting)
|
7.4%
4/54 • 2 years
|
3.2%
1/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
1.9%
1/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
9.3%
5/54 • 2 years
|
6.5%
2/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Ulcer, Esophagus
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
8/54 • 2 years
|
32.3%
10/31 • 2 years
|
11.5%
3/26 • 2 years
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
Other adverse events
| Measure |
Arm A, - Modified DCF
n=54 participants at risk
Drug Dose (mg/m2) Schedule
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
|
ARM B - Parent DCF With G-CSF
n=31 participants at risk
Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17
\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
|
Arm C - Modified DCF+ Trastuzumab
n=26 participants at risk
Treatment for Her2 Positive Participants
Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
|
|---|---|---|---|
|
Immune system disorders
Allerg react/hypersens (incl drug fever)
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.7%
2/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Cardiac disorders
Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Cardiac disorders
Cardiac General, other
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Infections and infestations
Colitis, infectious
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.6%
3/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Investigations
Creatinine
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
1.9%
1/54 • 2 years
|
12.9%
4/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
5/54 • 2 years
|
22.6%
7/31 • 2 years
|
15.4%
4/26 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
3/54 • 2 years
|
12.9%
4/31 • 2 years
|
19.2%
5/26 • 2 years
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.7%
2/54 • 2 years
|
9.7%
3/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
General disorders
Edema: trunk/genital
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
7.4%
4/54 • 2 years
|
12.9%
4/31 • 2 years
|
19.2%
5/26 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.4%
4/54 • 2 years
|
16.1%
5/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
19.2%
5/26 • 2 years
|
|
Gastrointestinal disorders
Fistula, GI- Small bowel NOS
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
5.6%
3/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Vascular disorders
Hematoma
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
7.4%
4/54 • 2 years
|
6.5%
2/31 • 2 years
|
15.4%
4/26 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Stoma (GI)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Stomach
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Injury, poisoning and procedural complications
Hemorrhage/Bleeding, other
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Vascular disorders
Hypotension
|
3.7%
2/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Ileus, GI (func obstruction of bowel)
|
5.6%
3/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Catheter-related
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Urinary(bladder)
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Abdomen NOS
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Lung (pneumonia)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Infections and infestations
Infection, other
|
3.7%
2/54 • 2 years
|
6.5%
2/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Investigations
INR
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Leak, GI- Leak NOS
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Investigations
Leukocytes (total WBC)
|
3.7%
2/54 • 2 years
|
3.2%
1/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Investigations
Lymphopenia
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Investigations
Metabolic/Lab - Other (specify)
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
1.9%
1/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Mucositis (func/sympt)- Oral cavity
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Right-sided
|
1.9%
1/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
14.8%
8/54 • 2 years
|
29.0%
9/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
9.3%
5/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Obstruction, GI- Colon
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Obstruction, GI- Small bowel NOS
|
3.7%
2/54 • 2 years
|
6.5%
2/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Obstruction, GI- Stomach
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
14.8%
8/54 • 2 years
|
19.4%
6/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Cardiac disorders
Pain - Cardiac/heart
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest/thorax NOS
|
0.00%
0/54 • 2 years
|
6.5%
2/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
General disorders
Pain - Other (specify)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Pain - Stomach
|
3.7%
2/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Perforation, GI- Cecum
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
0.00%
0/54 • 2 years
|
0.00%
0/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
7.4%
4/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Nervous system disorders
Syncope (fainting)
|
7.4%
4/54 • 2 years
|
3.2%
1/31 • 2 years
|
7.7%
2/26 • 2 years
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
1.9%
1/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
9.3%
5/54 • 2 years
|
6.5%
2/31 • 2 years
|
3.8%
1/26 • 2 years
|
|
Gastrointestinal disorders
Ulcer, Esophagus
|
0.00%
0/54 • 2 years
|
3.2%
1/31 • 2 years
|
0.00%
0/26 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
8/54 • 2 years
|
32.3%
10/31 • 2 years
|
11.5%
3/26 • 2 years
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
1.9%
1/54 • 2 years
|
0.00%
0/31 • 2 years
|
0.00%
0/26 • 2 years
|
Additional Information
Dr. Yelena Janjigian, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place