Trial Outcomes & Findings for Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy (NCT NCT01129206)
NCT ID: NCT01129206
Last Updated: 2016-06-01
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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
COMPLETED
PHASE2
6 participants
Approximately three years
2016-06-01
Participant Flow
This was a phase II single-arm, open label trial performed at The Ohio State University James Cancer Hospital.
Participant milestones
| Measure |
Arm I: Pralatrexate and Docetaxel
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy
Baseline characteristics by cohort
| Measure |
Arm I
n=6 Participants
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
|---|---|
|
Age, Continuous
|
63.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Approximately three yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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
| Measure |
Arm I: Pralatrexate and Docetaxel
n=6 Participants
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
RECIST Criteria Per CT
|
|---|---|---|
|
Overall Response
Stable disease
|
2 patients
|
—
|
|
Overall Response
Progressive disease
|
4 patients
|
—
|
SECONDARY outcome
Timeframe: Approximately three yearsProgression 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
Outcome measures
| Measure |
Arm I: Pralatrexate and Docetaxel
n=6 Participants
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
RECIST Criteria Per CT
|
|---|---|---|
|
Progression-free Survival (PFS)
|
1.9 months
Interval 0.8 to 7.2
|
—
|
SECONDARY outcome
Timeframe: Approximately five yearsOS was determined from the date of start of therapy to death frm any cause.
Outcome measures
| Measure |
Arm I: Pralatrexate and Docetaxel
n=6 Participants
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
RECIST Criteria Per CT
|
|---|---|---|
|
Overall Survival (OS)
|
5.5 months
Interval 0.8 to 11.7
|
—
|
SECONDARY outcome
Timeframe: Approximately three yearsPopulation: 2 patients not evaluable for response applying the PERCIST criteria per PET
Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.
Outcome measures
| Measure |
Arm I: Pralatrexate and Docetaxel
n=4 Participants
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
RECIST Criteria Per CT
n=6 Participants
|
|---|---|---|
|
Correlation of FDG PET Response With Response Rate
Progressive Disease
|
0 patients
|
4 patients
|
|
Correlation of FDG PET Response With Response Rate
Stable Disease
|
2 patients
|
2 patients
|
|
Correlation of FDG PET Response With Response Rate
Partial Response
|
2 patients
|
0 patients
|
Adverse Events
Arm I
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I
n=6 participants at risk
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
|
|---|---|
|
Investigations
Lymphopenia
|
100.0%
6/6 • Number of events 6
Toxicities were defined by the National Cancer Institutes CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2
Toxicities were defined by the National Cancer Institutes CTCAE version 3.0
|
|
Investigations
Leukopenia
|
33.3%
2/6 • Number of events 2
Toxicities were defined by the National Cancer Institutes CTCAE version 3.0
|
|
Gastrointestinal disorders
Mucocitis
|
33.3%
2/6 • Number of events 2
Toxicities were defined by the National Cancer Institutes CTCAE version 3.0
|
Additional Information
Tanios Bekaii Saab, MD
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place