Trial Outcomes & Findings for Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02569957)
NCT ID: NCT02569957
Last Updated: 2025-05-04
Results Overview
The two-sided Fisher's exact test with alpha 0.05 will be used to compare the proportions of subjects who demonstrate a downregulation of MCT4 between subjects treated with topotecan hydrochloride and NAC and topotecan hydrochloride alone.
TERMINATED
PHASE2
1 participants
Baseline to up to day 20 after first course of topotecan hydrochloride
2025-05-04
Participant Flow
Participant milestones
| Measure |
Arm I (Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
|
Arm II (Topotecan Hydrochloride, Acetylcysteine)
Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
Acetylcysteine: Given IV and PO
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
|
Arm II (Topotecan Hydrochloride, Acetylcysteine)
Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
Acetylcysteine: Given IV and PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
|
Arm II (Topotecan Hydrochloride, Acetylcysteine)
n=1 Participants
Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
Acetylcysteine: Given IV and PO
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
The two-sided Fisher's exact test with alpha 0.05 will be used to compare the proportions of subjects who demonstrate a downregulation of MCT4 between subjects treated with topotecan hydrochloride and NAC and topotecan hydrochloride alone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to day 20 after first course of topotecan hydrochloridePopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to day 29Population: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Compared pre-therapy and post- 1 cycle of therapy with a Fisher's exact test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Compared between the two arms using the log-rank test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Compared between the two arms using the log-rank test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Evaluated using the exact binomial confidence intervals and compared between the two arms using the Fisher's exact test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Compared between the two arms using the two-sample Wilcoxon test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.
Tabulated and reported with the corresponding exact binomial confidence intervals.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Topotecan Hydrochloride)
Arm II (Topotecan Hydrochloride, Acetylcysteine)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
|
Arm II (Topotecan Hydrochloride, Acetylcysteine)
n=1 participants at risk
Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Topotecan Hydrochloride: Given IV
Acetylcysteine: Given IV and PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Activated Partial Thromboplastin Time prolonged
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 9 • 8 months
|
|
Blood and lymphatic system disorders
ANC decreased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 10 • 8 months
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Creatine Increased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 8 • 8 months
|
|
General disorders
Dizziness
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 4 • 8 months
|
|
General disorders
Dry mouth
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 8 • 8 months
|
|
Renal and urinary disorders
Elevated WBC urine
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Gastrointestinal Pain
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
General disorders
Headache
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 3 • 8 months
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Renal and urinary disorders
Hypercalcemia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 6 • 8 months
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 5 • 8 months
|
|
Blood and lymphatic system disorders
Hypertension
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 4 • 8 months
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Hyponatremia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
Blood and lymphatic system disorders
INR increased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 9 • 8 months
|
|
General disorders
Insomnia
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
Blood and lymphatic system disorders
Lipase increased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 3 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue disorder
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 3 • 8 months
|
|
General disorders
Nausea
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 3 • 8 months
|
|
Nervous system disorders
Neuropathy
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
General disorders
Non-cardiac Chest pain
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
General disorders
Pain
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
Blood and lymphatic system disorders
Platelet Count decreased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 3 • 8 months
|
|
General disorders
Presyncope
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
General disorders
Sinusitis
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Surgical and medical procedures
Skin Biopsy
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Ear and labyrinth disorders
Tearing
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Renal and urinary disorders
UTI
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
|
Reproductive system and breast disorders
Vaginal Spotting
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 2 • 8 months
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 7 • 8 months
|
|
General disorders
Right side chest pain
|
—
0/0 • 8 months
|
100.0%
1/1 • Number of events 1 • 8 months
|
Additional Information
Russell Schilder
Sidney Kimmel Cancer Center at Thomas Jefferson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place