Normal saline administered intraperitoneally at defined times

Local anesthetic (ropivacaine) administered intraperitoneally at defined time intervals, similar to placebo arm

Ovarian Cancer

Experimental drug will be administered intraperitoneally

Ropivacaine

Placebo will be administered intraperitoneally

Saline Solution

Karolinska Hospital, Solna

Intra-Peritoneal Local Anaesthetics in Ovarian Cancer

A Randomised Double Blind, Multicentre Trial to Assess Time-interval Between Cytoreductive Surgery and Adjuvant Chemotherapy When Local Anaesthetic is Administered Intraperitoneally, Perioperatively

Days after surgery that the first dose of chemotherapeutic agent is given intravenously.

All complications associated with surgery and anaesthesia will be recorded

Number of patients alive at given time frame will be recorded

All study data will be retained at site of patient recruitment. Primary investigator and statistician will only have access to coded patient identity

Anil Gupta

Associate Professor

Karolinska Institutet

Karolinska University Hospital

Randomised, double blind, prospective, multicenter

Study drugs are blinded and administered perioperatively. Fully blinded for all (participants, assessors etc)

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.

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.

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 I (Topotecan Hydrochloride)

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

Arm II (Topotecan Hydrochloride, Acetylcysteine)

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

Proportion of Patients Who Demonstrate a Downregulation of MCT4

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.

Change in Expression Levels of Cav-1 in Tissue Samples

Change in Expression Levels of MCT1 in Tissue Samples

Change in Expression Levels of TOMM20 in Tissue Samples

Change in Expression Levels of FABP4 in Tissue Samples

Change in Expression Levels of HIF-1 Alpha in Tissue Samples

Change in Expression Levels of NFκB in Tissue Samples

Compared pre-therapy and post- 1 cycle of therapy with a Fisher's exact test.

Change in Number of Circulating Tumor Cells

Compared between the two arms using the log-rank test.

Progression-free Survival

Overall Survival

Evaluated using the exact binomial confidence intervals and compared between the two arms using the Fisher's exact test.

Objective Tumor Response Rates

Compared between the two arms using the two-sample Wilcoxon test.

Duration of Response

Tabulated and reported with the corresponding exact binomial confidence intervals.

Proportion of Patients Experiencing Adverse Events, Evaluated Using the National Cancer Institute CTCAE Version 4.0

Overall Study

Russell Schilder

Malignant Ovarian Endometrioid Tumor

Malignant Ovarian Serous Tumor

Recurrent Fallopian Tube Carcinoma

Recurrent Ovarian Carcinoma

Recurrent Primary Peritoneal Carcinoma

Topotecan Hydrochloride

Acetylcysteine

Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

Thomas Jefferson University

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

Evaluation of the Addition of N-Acetylcysteine to Topotecan in the Tumor Microenvironment of Persistent or Recurrent High Grade Endometrioid or Serous Ovarian Carcinoma

fallopian tube neoplasms/hypoxia

Intra-Peritoneal Local Anaesthetics in Ovarian Cancer

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

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