Brief Title
A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer
Official Title
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
Brief 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.
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Occurrence of limiting toxicity
Secondary Outcome
response rate
Condition
Epithelial Ovarian Carcinoma
Intervention
weekly paclitaxel
Study Arms / Comparison Groups
weekly paclitaxel with oncothermia
Description: Paclitaxel group are treated with weekly paclitaxel and oncothermia for 4-cycles.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
December 2014
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Kidong kim, MD, 82-31-787-7262, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02344095
Organization ID
KGOG3030
Responsible Party
Principal Investigator
Study Sponsor
Seoul National University Hospital
Study Sponsor
Kidong kim, MD, Study Director, Seoul National University Bundang Hospital,Gyeongg-ido,Repub
Verification Date
January 2015