Trial Outcomes & Findings for Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer (NCT NCT02112552)
NCT ID: NCT02112552
Last Updated: 2023-08-29
Results Overview
At the end of the study, the proportion of patients who tolerated the therapy will be estimated, along with corresponding 95% confidence intervals. Reasons for discontinuation of therapy will be categorized and summarized by computing frequencies.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Up to 18 weeks
Results posted on
2023-08-29
Participant Flow
Participants were recruited and enrolled into the study between. The 1st participant was enrolled on 4/10/2014 and the final participant was enrolled into the study on 4/5/2016. No further participants have been enrolled since April 2016.
4 participants consented but only 3 were enrolled. One participant failed screening due to the onset of an adverse event.
Participant milestones
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).
Paclitaxel: Given IV
Carboplatin: Given Intraperitoneal (IP)
3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Quality-of-Life Assessment: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).
Paclitaxel: Given IV
Carboplatin: Given Intraperitoneal (IP)
3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Quality-of-Life Assessment: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
n=4 Participants
CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).
Paclitaxel: Given IV
Carboplatin: Given IP
3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Quality-of-Life Assessment: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 weeksPopulation: Data was not collected/aggregated and therefore not analyzed for Degree of Tolerability
At the end of the study, the proportion of patients who tolerated the therapy will be estimated, along with corresponding 95% confidence intervals. Reasons for discontinuation of therapy will be categorized and summarized by computing frequencies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The duration of time from start of treatment to time of progression, or death, whichever happens first, assessed at 1 yearPopulation: Data was not collected/aggregated and therefore not analyzed for Progression Free Survival
The proportion of responders at one year will be estimated with the Kaplan-Meier method. Surrogate endpoint biomarkers including estrogen, progesterone, and Her2/neu receptor status will be correlated with progression-free survival using the Cox Proportional Hazards model, provided the availability of a sufficient number of events.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
n=4 participants at risk
CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).
Paclitaxel: Given IV
Carboplatin: Given IP
3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Quality-of-Life Assessment: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Blood and lymphatic system disorders
Neutropenia (febrile)
|
25.0%
1/4 • Number of events 2 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
n=4 participants at risk
CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).
Paclitaxel: Given IV
Carboplatin: Given IP
3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Quality-of-Life Assessment: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Investigations
Weight Loss
|
25.0%
1/4 • Number of events 2 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
|
Nervous system disorders
Peripheral Neuropathy
|
25.0%
1/4 • Number of events 1 • Minimally upon completion of radiation therapy at 26 weeks after treatment initiation. Further adverse event evaluations as clinically indicated.
4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.
|
Additional Information
Dr. Jessica Atrio, Professor, Department of Obstetrics & Gynecology and Women's Health
Albert Einstein College of Medicine - Montefiore Medical center
Phone: 917-721-6155
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place