RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.

Quick Facts

Study Start:2022-06-13

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05415709

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to understand (English-speaking), and willingness to sign a written, informed consent * Age \> 18 years old * Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by: * Biopsy/histology (either by interventional radiology or laparoscopy) OR * Cytology; If diagnosis is based on cytology the following criteria must be met: * Immunohistochemistry on the block from cytology to demonstrate Mullerian origin * Presence of pelvic mass AND CA 125 \> 200kU/I AND CA125/CEA ratio \> 25 at initial diagnosis * Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (diagnosed by computed tomography \[CT\]/magnetic resonance imaging \[MRI\], ultrasound, or laparoscopy) * Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon * Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery * Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin \[area under the curve (AUC) 5-6\] day \[D\]1 + paclitaxel \[175 mg/m\^2\] D1 every 3 weeks) * Following 3-4 cycles of NACT partial or complete response * Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery * Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2 * Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2 * Serum creatinine \< 1.4 mg/dL * Creatinine clearance \> 60 ml/min (Cockcroft-Gault formula) * White blood cell count \> 3.5 x 10\^9 cells/L * Absolute neutrophil count \> 1.5 kg/ul * Platelets \> 100,000/ul * Total bilirubin within 1.5 x normal institutional limits * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal * For quality of life assessment, baseline questionnaires should be filled in before randomization	* 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 * 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 * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia * Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery

Inclusion Criteria

Exclusion Criteria

* Ability to understand (English-speaking), and willingness to sign a written, informed consent
* Age \> 18 years old
* Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:
* Biopsy/histology (either by interventional radiology or laparoscopy) OR
* Cytology; If diagnosis is based on cytology the following criteria must be met:
* Immunohistochemistry on the block from cytology to demonstrate Mullerian origin
* Presence of pelvic mass AND CA 125 \> 200kU/I AND CA125/CEA ratio \> 25 at initial diagnosis
* Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (diagnosed by computed tomography \[CT\]/magnetic resonance imaging \[MRI\], ultrasound, or laparoscopy)
* Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon
* Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery
* Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin \[area under the curve (AUC) 5-6\] day \[D\]1 + paclitaxel \[175 mg/m\^2\] D1 every 3 weeks)
* Following 3-4 cycles of NACT partial or complete response
* Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery
* Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2
* Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2
* Serum creatinine \< 1.4 mg/dL
* Creatinine clearance \> 60 ml/min (Cockcroft-Gault formula)
* White blood cell count \> 3.5 x 10\^9 cells/L
* Absolute neutrophil count \> 1.5 kg/ul
* Platelets \> 100,000/ul
* Total bilirubin within 1.5 x normal institutional limits
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal
* For quality of life assessment, baseline questionnaires should be filled in before randomization

* 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
* 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
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
* Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Floor Backes, MD

PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

Floor Backes, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

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 Registration Dates

Study Start Date2022-06-13

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-06-13

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Serous Adenocarcinoma
Primary Peritoneal Endometrioid Adenocarcinoma
Primary Peritoneal Serous Adenocarcinoma
Stage III Fallopian Tube Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Stage III Primary Peritoneal Cancer AJCC v8
Stage IIIA Fallopian Tube Cancer AJCC v8
Stage IIIA Ovarian Cancer AJCC v8
Stage IIIA Primary Peritoneal Cancer AJCC v8
Stage IIIA1 Fallopian Tube Cancer AJCC v8
Stage IIIA1 Ovarian Cancer AJCC v8
Stage IIIA2 Fallopian Tube Cancer AJCC v8
Stage IIIA2 Ovarian Cancer AJCC v8
Stage IIIB Fallopian Tube Cancer AJCC v8
Stage IIIB Ovarian Cancer AJCC v8
Stage IIIB Primary Peritoneal Cancer AJCC v8
Stage IIIC Fallopian Tube Cancer AJCC v8
Stage IIIC Ovarian Cancer AJCC v8
Stage IIIC Primary Peritoneal Cancer AJCC v8
Stage IV Fallopian Tube Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Primary Peritoneal Cancer AJCC v8
Stage IVA Fallopian Tube Cancer AJCC v8
Stage IVA Ovarian Cancer AJCC v8
Stage IVA Primary Peritoneal Cancer AJCC v8
Stage IVB Fallopian Tube Cancer AJCC v8
Stage IVB Ovarian Cancer AJCC v8
Stage IVB Primary Peritoneal Cancer AJCC v8