Trial Outcomes & Findings for Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer (NCT NCT00258362)

NCT ID: NCT00258362

Last Updated: 2017-12-28

Results Overview

This estimate was determined by using a statistical method of analysis (Kaplan-Meier).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: 1 Year, 2 Years, 3 Years
• Results posted on: 2017-12-28

Participant Flow

42 patients consented originally, but 1 patient withdrew consent before receiving any treatment.

Participant milestones

Measure	Patients With Endometrial Cancer Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

Baseline characteristics by cohort

Measure	Patients With Endometrial Cancer n=41 Participants Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
Histology Endometroid + Serous	1 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	59.0 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants
Histology Endometroid	32 Participants n=5 Participants
Histology Serous	4 Participants n=5 Participants
Histology Mucinous	1 Participants n=5 Participants
Histology Adenosquamous	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year, 2 Years, 3 Years

Population: Two patients with recurrent disease at study entry were excluded from this analysis.

This estimate was determined by using a statistical method of analysis (Kaplan-Meier).

Outcome measures

Measure	Patients With Endometrial Cancer n=39 Participants Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Percent of Patients Estimated to be Progression-Free and Alive 1 Year	86 Percentage of Patients Interval 69.0 to 93.8
Percent of Patients Estimated to be Progression-Free and Alive 2 Years	76 Percentage of Patients Interval 56.8 to 87.1
Percent of Patients Estimated to be Progression-Free and Alive 3 Years	68 Percentage of Patients Interval 44.6 to 83.2

SECONDARY outcome

Timeframe: 1 Year, 2 Years, 3 Years

Population: All 41 patients were included in this analysis.

This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.

Outcome measures

Measure	Patients With Endometrial Cancer n=41 Participants Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Percent of Patients Estimated to be Alive 1 Year	94 Percentage of Patients Interval 79.5 to 98.6
Percent of Patients Estimated to be Alive 2 Years	91 Percentage of Patients Interval 74.2 to 97.0
Percent of Patients Estimated to be Alive 3 Years	80 Percentage of Patients Interval 45.4 to 93.6

Adverse Events

Patients With Endometrial Cancer

Serious events: 8 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients With Endometrial Cancer n=41 participants at risk Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Renal and urinary disorders Bladder Infection	4.9% 2/41 • Number of events 2 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Infections and infestations Blood Infection	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Dehydration	4.9% 2/41 • Number of events 2 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Infections and infestations Febrile Neutropenia	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Blood and lymphatic system disorders Lymphocele	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Respiratory, thoracic and mediastinal disorders Metastatic disease to lung	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Nausea	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Renal and urinary disorders Stricture/stenosis of ureter	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Vascular disorders Thrombosis/embolism	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Vomiting	2.4% 1/41 • Number of events 1 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).

Other adverse events

Measure	Patients With Endometrial Cancer n=41 participants at risk Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
Blood and lymphatic system disorders Anemia	75.6% 31/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Anorexia	17.1% 7/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Constipation	48.8% 20/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Skin and subcutaneous tissue disorders Dermatology	53.7% 22/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Diarrhea	39.0% 16/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Endocrine disorders Endocrine	17.1% 7/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
General disorders Fatigue	90.2% 37/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
General disorders Fever	7.3% 3/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Blood and lymphatic system disorders Hemorrhage	7.3% 3/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Infections and infestations Infection	12.2% 5/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Blood and lymphatic system disorders Leukopenia	58.5% 24/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Blood and lymphatic system disorders Lymphatics	9.8% 4/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Musculoskeletal and connective tissue disorders Musculoskeletal soft tissue	14.6% 6/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Nervous system disorders Neuropathy	22.0% 9/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Blood and lymphatic system disorders Neutropenia	51.2% 21/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Eye disorders Ocular, visual	7.3% 3/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
General disorders Pain	46.3% 19/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Respiratory, thoracic and mediastinal disorders Pulmonary, upper respiratory	14.6% 6/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Renal and urinary disorders Renal, genitourinary	9.8% 4/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Reproductive system and breast disorders Sexual reproductive function	9.8% 4/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Blood and lymphatic system disorders Thrombocytopenia	48.8% 20/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Vomiting	17.1% 7/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
Gastrointestinal disorders Weight loss	7.3% 3/41 • Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported. Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).

Additional Information

Melissa Geller, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-626-3111

Email: gelle005@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place