Health Trials

Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer

ConditionsFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaFallopian Tube Serous AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mucinous AdenocarcinomaOvarian Serous AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaStage III Fallopian Tube Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage IIIA Fallopian Tube Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Primary Peritoneal Cancer AJCC v8Stage IIIA1 Fallopian Tube Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Fallopian Tube Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Fallopian Tube Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Primary Peritoneal Cancer AJCC v8Stage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.

Eligibility criteria

Qualifiers

Ability to understand (English-speaking), and willingness to sign a written, informed consent

Age > 18 years old

Biopsy/histology (either by interventional radiology or laparoscopy) OR

Immunohistochemistry on the block from cytology to demonstrate Mullerian origin

Disqualifiers

History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Low grade serious carcinoma of the ovary or borderline ovarian tumors

History or current diagnosis of inflammatory bowel disease

History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel

Trial design

Treatments tested in this trial

  • Carboplatin
  • Cisplatin
  • Cytoreductive Surgery
  • Hyperthermic Intraperitoneal Chemotherapy
  • Paclitaxel
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Biospecimen Collection
  • Diagnostic Imaging

Treatment groups

45 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov