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Trial record 48 of 526 for:    "Primary Peritoneal Carcinoma"

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

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ClinicalTrials.gov Identifier: NCT02344095
Recruitment Status : Unknown
Verified January 2015 by Yong Beom Kim, MD, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 22, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Yong Beom Kim, MD, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Drug: weekly paclitaxel Drug: weekly cisplatin Device: oncothermia Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015


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.
Drug: weekly cisplatin
Patients are treated with weekly cisplatin 40mg/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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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 (%)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344095


Contacts
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Contact: Kidong kim, MD 82-31-787-7262 kidong.kim.md@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463707
Contact: Kidong Kim       kidong.kim.md@gmail.com   
Sub-Investigator: Kidong Kim         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Kidong kim, MD Seoul National University Bundang Hospital,Gyeongg-ido,Repub

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Responsible Party: Yong Beom Kim, MD, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02344095     History of Changes
Other Study ID Numbers: KGOG3030
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Yong Beom Kim, MD, Seoul National University Hospital:
recurrent, persistent

Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action