Overview

A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer

Status:
Unknown status
Trial end date:
2015-10-01
Target enrollment:
0
Participant gender:
Female
Summary
The investigators aimed to evaluate the safety of weekly paclitaxel with oncothermia and weekly cisplatin with oncothermia in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. This trial is a randomized phase 1 trial. The investigators planned to perform it for 1 year. In this trial, a total of 12 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma are randomly assigned to either a paclitaxel or cisplatin group in ratio of 1 to 1. Paclitaxel group are treated with weekly paclitaxel and oncothermia. Cisplatin group are treated with weekly cisplatin and oncothermia. In each group, limiting toxicity is evaluated after treating 3 patients for 4-cycles. Primary endpoint is occurrence of limiting toxicity. Secondary endpoints are response rate, progression-free survival, overall-survival, quality of life, pain, fatigue and compliance rate.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Paclitaxel
Criteria
Inclusion Criteria:

- Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal
carcinoma (At the first diagnosis, pathologic findings should be confirmed.)

- Response assessments that are possible by using radiologic tests or tumor markers

- The number of chemotherapeutic regimens that were previously used ≤ 2

- Adequate hematologic, hepatic, and renal functions

- ECOG performance status 0 - 2

Exclusion Criteria:

- Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal
carcinoma that are located on the part of body where it is impossible to deliver
energy by using oncothermia (EHY 2000) probe

- Neurotoxicity ≥ grade 2

- Pacemaker user

- Large metal materials such as artificial joint that are kept in the body

- Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal
carcinoma that are located on the part of body where got previously radiation therapy