Trial Outcomes & Findings for Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery (NCT NCT00448760)
NCT ID: NCT00448760
Last Updated: 2017-02-07
Results Overview
No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
8 - 16 weeks
Results posted on
2017-02-07
Participant Flow
Participant milestones
| Measure |
Neoadjuvant + Adjuvant Chemotherapy
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Neoadjuvant + Adjuvant Chemotherapy
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Single Arm
n=29 Participants
5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Gender
Female
|
23 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 - 16 weeksNo evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.
Outcome measures
| Measure |
Single Arm
n=24 Participants
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Pathologic Complete Response
|
16.7 percentage of participants
Interval 5.9 to 34.2
|
SECONDARY outcome
Timeframe: 8 - 16 weeksOverall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest: Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values. Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.
Outcome measures
| Measure |
Single Arm
n=24 Participants
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Clinical Response
|
72.4 percentage of participants
Interval 55.7 to 85.5
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Single Arm
n=26 Participants
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Median Progression-free Survival (PFS)
|
13.6 months
Interval 9.0 to 24.0
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Single Arm
n=29 Participants
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Overall Survival
|
21.4 months
Interval 13.6 to 32.1
|
Adverse Events
Single Arm
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=29 participants at risk
Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Grade 3 Neutropenia
|
27.6%
8/29
|
|
Blood and lymphatic system disorders
Grade 4 Neutropenia
|
10.3%
3/29
|
|
Blood and lymphatic system disorders
Grade 3 Febrile Neutropenia
|
10.3%
3/29
|
|
Blood and lymphatic system disorders
Grade 3Thrombocytopenia
|
3.4%
1/29
|
|
General disorders
Grade 3 Fatigue
|
31.0%
9/29
|
|
Gastrointestinal disorders
Grade 3 Diarrhea
|
17.2%
5/29
|
|
General disorders
Grade 3 Deep Venous Thrombosis
|
3.4%
1/29
|
|
General disorders
Grade 3 Nausea
|
3.4%
1/29
|
Other adverse events
Adverse event data not reported
Additional Information
Bach Ardalan MD, Professor
UM/Sylvester Comprehensive Cancer Center
Phone: 305-243-4909
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place