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

Ovarian Endometrioid Adenocarcinoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415709
• Other study ID #: OSU-20277
• Secondary ID: NCI-2021-06207
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 13, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of intravenous (IV) cisplatin on the day prior to interval cytoreductive surgery (CRS) to administration of hyperthermic intraepithelial chemotherapy (HIPEC) with cisplatin at the completion of CRS versus standard chemotherapy and interval surgery. SECONDARY OBJECTIVES: I. Feasibility of each of the treatment options. II. Treatment delays. III. Perioperative outcomes. IV. Quality of life/patient reported outcomes. V. Recurrence free survival (RFS) and overall survival (OS). OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM I: No chemotherapy immediately before, during or after surgery. Carboplatin/paclitaxel is given 3-4 weeks prior to surgery and again 2-4 weeks after surgery. ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval debulking surgery ARM III: Patients receive cisplatin IV the day prior to interval debulking surgery After completion of study treatment, patients are followed up for up to 30 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Carcinoma, Endometrioid
• Carcinoma, Ovarian Epithelial
• Cystadenocarcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube Mucinous Adenocarcinoma
• Fallopian Tube Neoplasms
• Fallopian Tube Serous Adenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian Mucinous Adenocarcinoma
• Ovarian Neoplasms
• Ovarian Serous Adenocarcinoma
• Peritoneal Neoplasms
• 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

Intervention

Drug:
• Carboplatin
Given IV
• Cisplatin
Given IV

Procedure:
• Cytoreductive Surgery
Undergo CRS

Drug:
• Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
• Paclitaxel
Given IV

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chemotherapy-related adverse events	Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.	Up to 30 days after perioperative treatment
Secondary	Feasibility of chemotherapy immediately perioperatively	Percentage of patients able to receive planned chemotherapy the day prior to surgery or HIPEC on day of surgery	1 Day prior to surgery and 1 day of surgery
Secondary	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	Up to 1 year
Secondary	Recurrence free survival	time between surgery and recurrence	For 3-5 years after study
Secondary	Tumor response	tumor response evaluated per clinical standards	Up to 1 year
Secondary	Quality of life (QOL) assessment EORTC QLQ-C30	Validated quality of life assessments	Baseline up to 6 months post-treatment

External Links

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