Trial Outcomes & Findings for Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001) (NCT NCT00522795)
NCT ID: NCT00522795
Last Updated: 2020-02-17
Results Overview
Per pathology review post surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
At Surgery approximately 4weeks after last treatment
Results posted on
2020-02-17
Participant Flow
Accrual closed in August 2009, 40 patients were enrolled
Participant milestones
| Measure |
PPX, Cisplatin, Radiation
* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
Baseline characteristics by cohort
| Measure |
PPX, Cisplatin, Radiation
n=40 Participants
* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=99 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At Surgery approximately 4weeks after last treatmentPopulation: Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.
Per pathology review post surgery
Outcome measures
| Measure |
PPX, Cisplatin, Radiation
n=40 Participants
|
|---|---|
|
Complete Pathologic Response
|
12 participants
|
Adverse Events
PPX, Cisplatin, Radiation
Serious events: 14 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PPX, Cisplatin, Radiation
n=40 participants at risk
* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX
|
|---|---|
|
Investigations
esophagitis, nauseam dehydration, electrolyte imbalance, potassium and mood alteration
|
2.5%
1/40 • Number of events 1
|
|
Investigations
allergic reaction/hypersensitivity
|
2.5%
1/40 • Number of events 1
|
|
Investigations
nausea, dehydration, esophagitis, death
|
2.5%
1/40 • Number of events 1
|
|
Investigations
multiorgan failure
|
2.5%
1/40 • Number of events 1
|
|
Investigations
leukopenia, esophagitis, dehydration, nausea, vomiting, neutropenia, hypotension
|
2.5%
1/40 • Number of events 1
|
|
Investigations
hyperglycemia, dehydration
|
2.5%
1/40 • Number of events 1
|
|
Investigations
infection of gallbladder with normal ANC
|
2.5%
1/40 • Number of events 1
|
|
Investigations
dysphagia, dizziness, dehydration
|
2.5%
1/40 • Number of events 1
|
|
Investigations
hypokalemia, hypomagnesemia, weakness, anorexia, opportunistic infection
|
2.5%
1/40 • Number of events 1
|
|
Investigations
thrombosis, hematoma, hypomagnesemia, extrapyramidal/restless
|
2.5%
1/40 • Number of events 2
|
|
Investigations
nausea, vomiting, weakness, ischemic colitis
|
2.5%
1/40 • Number of events 1
|
|
Investigations
thrombosis/embolism
|
2.5%
1/40 • Number of events 1
|
|
Investigations
infection with normal ANC (cellulitis) and albumin
|
2.5%
1/40 • Number of events 1
|
|
Investigations
pneumothorax
|
2.5%
1/40 • Number of events 1
|
|
Investigations
DVT
|
2.5%
1/40 • Number of events 1
|
|
Investigations
acute vascular leak, GI other, hypotension, anorexia, hypothermia,INR
|
2.5%
1/40 • Number of events 1
|
|
Investigations
abdominal pain and dehydration
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
PPX, Cisplatin, Radiation
n=40 participants at risk
* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX
|
|---|---|
|
Investigations
esophagitis
|
5.0%
2/40 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place