Trial Outcomes & Findings for Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma (NCT NCT00582205)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

3 years

Results posted on

2021-05-19

Participant milestones
Measure	Paclitaxel, Cisplatin IP There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Overall Study STARTED	21
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	10

Withdrawal data not reported

Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Baseline characteristics by cohort
Measure	Paclitaxel, Cisplatin IP n=21 Participants There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

Timeframe: 3 years

Outcome measures
Measure	Paclitaxel, Cisplatin IP n=21 Participants There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.	7 Participants

Timeframe: 3 years

Outcome measures
Measure	Paclitaxel, Cisplatin IP n=17 Participants There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity	7 Participants

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events
Measure	Paclitaxel, Cisplatin IP n=21 participants at risk There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Gastrointestinal disorders small bowel obstruction	4.8% 1/21 • Number of events 1

Other adverse events
Measure	Paclitaxel, Cisplatin IP n=21 participants at risk There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Blood and lymphatic system disorders Neutropenia	28.6% 6/21 • Number of events 6

University of Oklahoma

Phone: 405-271-8707