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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Given IV

  • Cisplatin

    Drug

    Given IV

  • Cytoreductive Surgery

    Procedure/Surgery

    Undergo CRS

  • Hyperthermic Intraperitoneal Chemotherapy

    Drug

    Undergo HIPEC

  • Paclitaxel

    Drug

    Given IV

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Biospecimen Collection

    Procedure/Surgery

    Undergo stool sample collection

  • Diagnostic Imaging

    Procedure/Surgery

    Undergo diagnostic imaging

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Arm I (carboplatin, paclitaxel, CRS, cisplatin)Experimental treatment 8 interventions
Group B: Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Incidence of chemotherapy-related adverse events

Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

Time frame
30 days from perioperative treatment

Secondary outcomes

1

Feasibility of chemotherapy immediately perioperatively

Percentage of patients able to receive planned chemotherapy the day prior to surgery or HIPEC on day of surgery

Time frame
1 Day prior to surgery and 1 day of surgery
2

Percentage of patients in Arm C with a treatment free interval of < 8 weeks

Percentage of patients in Arm C with a treatment free interval of \< 8 weeks

Time frame
Up to 1 year
3

Recurrence free survival

time between surgery and recurrence

Time frame
For 3-5 years after study
4

Tumor response

tumor response evaluated per clinical standards

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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