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

July 10, 2024 updated by: Yong Beom Kim, MD, Seoul National University Hospital

A Randomized Phase 1 Trial Evaluating 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is a randomized phase 1 trial. We planned to perform it for 1 year. Subjects of study are patients diagnosed as recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. The number of subjects of study is 12 patients (If patients cannot be assessed, they can be replaced with new patients). All subjects who were randomly assigned, are treated with weekly paclitaxel or weekly cisplatin. In paclitaxel group, patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks. In cisplatin group, patients are treated with weekly cisplatin 40mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks. Thermotherapy is performed by applying oncothermia (EHY 2000) probe on the part of body where tumor is located and delivering energy. It is performed on day 1, 4, 8, 11, 15, 18, 21, and 24 (8 times in total every cycle). Oncothermia can be performed a day earlier than scheduled day or a day later than scheduled day. It takes 60 minutes to treat a site for oncothermia. Energy is gradually increased from 60W to 140W. With tumors at multiple sites, oncothermia is performed several times changing sites that apply probe and type of probes. Oncothermia is performed for 60 minutes per each application. 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. In group that limiting toxicity occur in the rate equal to or less than 1 patient, limiting toxicity is evaluated after treating 3 additional patients for 4-cycles. When limiting toxicity occur in the rate equal to or less than one of six assessable patients, it is considered that the specific therapy is safe enough to be used in phase 2 trial. Primary endpoint is occurrence of limiting toxicity. Secondary endpoints are response rate, progression-free survival, overall-survival, quality of life, toxicity, pain, fatigue and compliance rate. Patients visit twice a week until 4-cycles are completed or progression of disease is confirmed.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: weekly paclitaxel with oncothermia
Paclitaxel group are treated with weekly paclitaxel and oncothermia for 4-cycles.
Drug: weekly paclitaxel
Patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks
Device: oncothermia

Thermotherapy is performed by applying oncothermia (EHY 2000) probe on the part of body where tumor is located and delivering energy. It is performed on day 1, 4, 8, 11, 15, 18, 21, and 24 (8 times in total every cycle). Oncothermia can be performed a day earlier than scheduled day or a day later than scheduled day. With tumors at multiple sites, oncothermia is performed several times changing sites that apply probe and type of probes.

- It takes 60 minutes to treat a site for oncothermia. Energy is gradually increased from 60W to 140W.
Experimental: weekly cisplatin with oncothermia
Cisplatin group are treated with weekly cisplatin and oncothermia for 4-cycles.
Device: oncothermia

Thermotherapy is performed by applying oncothermia (EHY 2000) probe on the part of body where tumor is located and delivering energy. It is performed on day 1, 4, 8, 11, 15, 18, 21, and 24 (8 times in total every cycle). Oncothermia can be performed a day earlier than scheduled day or a day later than scheduled day. With tumors at multiple sites, oncothermia is performed several times changing sites that apply probe and type of probes.

- It takes 60 minutes to treat a site for oncothermia. Energy is gradually increased from 60W to 140W.

Drug: weekly cisplatin
Patients are treated with weekly cisplatin 40mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of limiting toxicity
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed.
8 cycles up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed.
8 cycles up to 1 year
progression-free survival
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed.
8 cycles up to 1 year
overall-survival
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed.
8 cycles up to 1 year
quality of life, assessed with the Korean version of WHO Quality of Life-BREF (WHOQOL-BREF).
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Quality of life would be assessed with the Korean version of WHO Quality of Life-BREF (WHOQOL-BREF).
8 cycles up to 1 year
pain, assessed with the Korean version of the brief pain inventory (BPI).
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Pain would be assessed with the Korean version of the brief pain inventory (BPI).
8 cycles up to 1 year
fatigue, assessed with the Korean version of the Brief Fatigue Inventory (BFI).
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Fatigue would be assessed with the Korean version of the Brief Fatigue Inventory (BFI).
8 cycles up to 1 year
compliance rate
Time Frame: 8 cycles up to 1 year
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Compliance rate would be assessed with the number of patients that are dropped out from current clinical trial based on other reasons instead of disease. It would be recorded as compliance rate = the number of patients that are dropped out due to other reasons/the number of total patients · 100 (%)
8 cycles up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Kidong kim, MD, Seoul National University Bundang Hospital,Gyeongg-ido,Repub

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

November 1, 2014

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimated)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG3030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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