Trial Outcomes & Findings for Papillary Serous Carcinoma of the Endometrium (NCT NCT00515073)
NCT ID: NCT00515073
Last Updated: 2014-07-03
Results Overview
The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Assessment at 2 years and 5 years
Results posted on
2014-07-03
Participant Flow
Recruitment Period: April 30, 2001 to November 18, 2009 with actual enrollment occuring October 2001 through July 2009 at University of Texas (UT) MD Anderson Cancer Center and MD Anderson Cancer Center Orlando.
Two participants of 32 were enrolled but not included in group assignment due to ineligibility.
Participant milestones
| Measure |
Paclitaxel (Taxol) + Pelvic Radiation
Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Paclitaxel (Taxol) + Pelvic Radiation
Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Papillary Serous Carcinoma of the Endometrium
Baseline characteristics by cohort
| Measure |
Paclitaxel (Taxol) + Pelvic Radiation
n=30 Participants
Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessment at 2 years and 5 yearsPopulation: Two participants were inevaluable.
The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.
Outcome measures
| Measure |
Paclitaxel (Taxol) + Pelvic Radiation
n=28 Participants
Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
|
|---|---|
|
Overall Survival at 2 Years and 5 Years
2 Years
|
93 percentage of participants
|
|
Overall Survival at 2 Years and 5 Years
5 Years
|
85 percentage of participants
|
Adverse Events
Paclitaxel (Taxol) + Pelvic Radiation
Serious events: 15 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel (Taxol) + Pelvic Radiation
n=30 participants at risk
Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
GRANULOCYTOPENIA
|
3.3%
1/30 • Number of events 1 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
FATIGUE
|
33.3%
10/30 • Number of events 10 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
5/30 • Number of events 5 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
VOMITING
|
3.3%
1/30 • Number of events 1 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
DIARRHEA
|
43.3%
13/30 • Number of events 13 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
PAIN, ABDOMEN
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Nervous system disorders
HEADACHE
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
20.0%
6/30 • Number of events 7 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Psychiatric disorders
ANXIETY
|
3.3%
1/30 • Number of events 1 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
PAIN, CHEST
|
3.3%
1/30 • Number of events 1 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Musculoskeletal and connective tissue disorders
PAIN, BONE
|
10.0%
3/30 • Number of events 3 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.3%
1/30 • Number of events 1 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Infections and infestations
INFECTION
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Metabolism and nutrition disorders
ANOREXA
|
16.7%
5/30 • Number of events 5 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
Other adverse events
| Measure |
Paclitaxel (Taxol) + Pelvic Radiation
n=30 participants at risk
Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
|
|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
6.7%
2/30 • Number of events 3 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Skin and subcutaneous tissue disorders
DIAPHORESIS
|
10.0%
3/30 • Number of events 3 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
DIARRHEA
|
26.7%
8/30 • Number of events 12 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
FATIGUE
|
23.3%
7/30 • Number of events 9 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Investigations
FEVER WITHOUT NEUTROPENIA
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Blood and lymphatic system disorders
GRANULOCYTOPENIA
|
10.0%
3/30 • Number of events 3 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Nervous system disorders
HEADACHE
|
13.3%
4/30 • Number of events 4 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
13.3%
4/30 • Number of events 4 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
30.0%
9/30 • Number of events 9 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Musculoskeletal and connective tissue disorders
MOTOR SKILL
|
13.3%
4/30 • Number of events 4 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
MUCOSITIS (CLINICAL EXAM) ORAL CAVITY
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
MYALGIA
|
16.7%
5/30 • Number of events 11 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
NAUSEA
|
10.0%
3/30 • Number of events 7 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
PAIN (ABDOMEN NOS)
|
6.7%
2/30 • Number of events 6 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
PAIN
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
General disorders
RIGORS, CHILLS
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 5 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Nervous system disorders
NEUROPATHY
|
53.3%
16/30 • Number of events 16 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
ANOREXIA
|
13.3%
4/30 • Number of events 4 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Blood and lymphatic system disorders
ANEMIA
|
30.0%
9/30 • Number of events 9 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Gastrointestinal disorders
RECTAL BLEEDING
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
|
Infections and infestations
INFECTION
|
6.7%
2/30 • Number of events 2 • Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
|
Additional Information
Anuja Jhingran, MD / Professor, Radiation Oncology Department
University of Texas MD Anderson Cancer Center
Phone: 713-563-6900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place