Trial Outcomes & Findings for A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers (NCT NCT01659554)

Results Overview

The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

5 years

Results posted on

2017-03-10

Participant Flow

Subjects were screened and enrolled during 10/23/2012 to 08/20/2013.

Participant milestones

Participant milestones
Measure	Intraoperative Cisplatin Followed by IP Chemotherapy Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intraoperative Cisplatin Followed by IP Chemotherapy Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;
Overall Study Study Termination	4

Baseline Characteristics

A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraoperative Cisplatin Followed by IP Chemotherapy n=4 Participants Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: zero participants analyzed due to early termination of study

The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 5 years

Population: zero participants analyzed due to early termination of study

Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years (survival)

Population: zero participants analyzed due to early termination of study

Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years, survival

Population: zero participants analyzed due to early termination of study

Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).

Outcome measures

Outcome data not reported

Adverse Events

Intraoperative Cisplatin Followed by IP Chemotherapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intraoperative Cisplatin Followed by IP Chemotherapy n=4 participants at risk Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;
Gastrointestinal disorders Ileus, Grade 3	25.0% 1/4 • Number of events 1
Infections and infestations Grade 2 Abdominal Pain	25.0% 1/4 • Number of events 1
Infections and infestations IP drain infection, grade 3	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Nausea & vomiting	25.0% 1/4 • Number of events 1
Renal and urinary disorders No Oliguric Acute Renal Injury	25.0% 1/4 • Number of events 1
Renal and urinary disorders Urinary Trasct Infection Grade 3	25.0% 1/4 • Number of events 1
Infections and infestations Right Shoulder cellulitis	25.0% 1/4 • Number of events 1
Infections and infestations Fever with catheter related infection	25.0% 1/4 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Reena M. Vattakalam, CCRP

Columbia University Medical Center

Phone: 212-342-6895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place