Trial Outcomes & Findings for Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer (NCT NCT00267488)
NCT ID: NCT00267488
Last Updated: 2012-07-11
Results Overview
Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions
COMPLETED
PHASE2
70 participants
Week 0 to Week 98 when endpoints were met
2012-07-11
Participant Flow
Participant milestones
| Measure |
Topotecan Hydrochloride
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Topotecan Hydrochloride
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Overall Study
Sponsor Terminated Study
|
9
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Other (Disease Progression)
|
1
|
Baseline Characteristics
Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Topotecan Hydrochloride
n=37 Participants
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Age Continuous
|
62.8 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Heritage/African American
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 98 when endpoints were metPopulation: Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.
Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions
Outcome measures
| Measure |
Topotecan Hydrochloride
n=37 Participants
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Best Overall Response
Complete Response
|
0 Participants
|
|
Best Overall Response
Partial Response
|
1 Participants
|
|
Best Overall Response
Stable Disease
|
9 Participants
|
|
Best Overall Response
Progressive Disease
|
23 Participants
|
|
Best Overall Response
Unknown
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 19 when endpoints were metPopulation: Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.
Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.
Outcome measures
| Measure |
Topotecan Hydrochloride
n=37 Participants
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Time to Progression
25th percentile
|
7.3 Weeks
Interval 6.9 to 8.1
|
|
Time to Progression
Median percentile
|
8.7 Weeks
Interval 7.9 to 11.1
|
|
Time to Progression
75th percentile
|
15.3 Weeks
Interval 9.0 to 19.1
|
SECONDARY outcome
Timeframe: Week 0 to Week 98Population: Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.
Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.
Outcome measures
| Measure |
Topotecan Hydrochloride
n=37 Participants
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Overall Survival
25th percentile
|
20.4 Weeks
Interval 10.1 to 31.7
|
|
Overall Survival
Median percentile
|
47.3 Weeks
Interval 25.7 to 69.7
|
|
Overall Survival
75th percentile
|
89.3 Weeks
Interval 61.6 to 98.1
|
SECONDARY outcome
Timeframe: Week 0 to week 98The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0 to week 98The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0 to week 98Population: Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.
AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.
Outcome measures
| Measure |
Topotecan Hydrochloride
n=37 Participants
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Fatigue
|
15 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Nausea
|
14 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Constipation
|
12 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Abdominal Pain
|
11 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Vomiting
|
8 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Hypokalemia
|
7 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Anorexia
|
6 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Dyspnea
|
6 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Diarrhea
|
6 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Dizziness
|
6 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Headache
|
6 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
AE: Insomnia
|
6 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Abdominal Pain
|
2 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Gastrointestinal hemorrhage
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Intestinal obstruction
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Rectal Hemorrhage
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Vomiting
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Pulmonary Embolism
|
3 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Dyspnea
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Bacteremia
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Streptococcal Bacteremia
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Cerebral ischemia
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Cerebral infarction
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Incisional hernia, obstructive
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Dehydration
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
SAE: Embolism venous
|
1 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
Alive at last contact-when follow-up ended
|
9 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
Deaths - any subject
|
28 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
Cause of Death - Disease of Study
|
25 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
Cause of Death - Non-Hematological toxicity
|
2 Number of Events
|
|
Safety and Tolerability as Summarized Through Adverse Event Reporting
Cause of Death - Other-Brain Metastases
|
1 Number of Events
|
Adverse Events
Topotecan Hydrochloride
Serious adverse events
| Measure |
Topotecan Hydrochloride
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37
|
|
Gastrointestinal disorders
Gastrointestinal hemorrahage
|
2.7%
1/37
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
2.7%
1/37
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.7%
1/37
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
8.1%
3/37
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37
|
|
Infections and infestations
Bacteremia
|
2.7%
1/37
|
|
Infections and infestations
Streptococcal Infection
|
2.7%
1/37
|
|
Musculoskeletal and connective tissue disorders
Incisional hernia obstructive
|
2.7%
1/37
|
|
General disorders
Dehydration
|
2.7%
1/37
|
|
Vascular disorders
Embolism venous
|
2.7%
1/37
|
Other adverse events
| Measure |
Topotecan Hydrochloride
Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
|
|---|---|
|
General disorders
Fatigue
|
40.5%
15/37
|
|
Gastrointestinal disorders
Nausea
|
37.8%
14/37
|
|
Gastrointestinal disorders
Constipation
|
32.4%
12/37
|
|
Gastrointestinal disorders
Abdominal pain
|
29.7%
11/37
|
|
Gastrointestinal disorders
Vomiting
|
21.6%
8/37
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.9%
7/37
|
|
Metabolism and nutrition disorders
Anorexia
|
16.2%
6/37
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.2%
6/37
|
|
Gastrointestinal disorders
Diarrhea
|
16.2%
6/37
|
|
General disorders
Dizziness
|
16.2%
6/37
|
|
Psychiatric disorders
Insomnia
|
16.2%
6/37
|
|
Nervous system disorders
Headache
|
16.2%
6/37
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.8%
4/37
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37
|
|
General disorders
Hot Flush
|
10.8%
4/37
|
|
General disorders
Pain
|
10.8%
4/37
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolanyngeal pain
|
10.8%
4/37
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
3/37
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
8.1%
3/37
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.1%
3/37
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
8.1%
3/37
|
|
Cardiac disorders
Chest Pain
|
8.1%
3/37
|
|
Vascular disorders
Edema Peripheral
|
8.1%
3/37
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
3/37
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.1%
3/37
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
8.1%
3/37
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
3/37
|
|
Renal and urinary disorders
Urinary Tract infection
|
8.1%
3/37
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.4%
2/37
|
|
Blood and lymphatic system disorders
Blood Alkaline Phosphatase increased
|
5.4%
2/37
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
2/37
|
|
Hepatobiliary disorders
ALT increased
|
5.4%
2/37
|
|
Nervous system disorders
Anxiety
|
5.4%
2/37
|
|
General disorders
Chills
|
5.4%
2/37
|
|
Gastrointestinal disorders
Dry Mouth
|
5.4%
2/37
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.4%
2/37
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
5.4%
2/37
|
|
Metabolism and nutrition disorders
Blood Magnesium decreased
|
5.4%
2/37
|
|
General disorders
Pain in Extremity
|
5.4%
2/37
|
|
Renal and urinary disorders
Pollakiuria
|
5.4%
2/37
|
|
General disorders
Pyrexia
|
5.4%
2/37
|
|
Renal and urinary disorders
Vaginal Discharge
|
5.4%
2/37
|
|
Metabolism and nutrition disorders
Weight Decrease
|
5.4%
2/37
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER