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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

Primary Purpose

Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Carboplatin

Cisplatin

Cytoreductive Surgery

Hyperthermic Intraperitoneal Chemotherapy

Paclitaxel

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional treatment trial for Fallopian Tube Endometrioid Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (carboplatin, paclitaxel, CRS)

Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)

Arm III (carboplatin, paclitaxel, CRS, cisplatin)

Arm Description

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.

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 II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval debulking surgery

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 III: Patients receive cisplatin IV the day prior to interval debulking surgery

Outcomes

Primary Outcome Measures

Incidence of chemotherapy-related adverse events

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

Secondary Outcome Measures

Feasibility of chemotherapy immediately perioperatively

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

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

Recurrence free survival

time between surgery and recurrence

Tumor response

tumor response evaluated per clinical standards

Quality of life (QOL) assessment EORTC QLQ-C30

Validated quality of life assessments

Full Information

NCT ID

NCT05415709

First Posted

April 5, 2022

Last Updated

September 16, 2022

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05415709

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 13, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (carboplatin, paclitaxel, CRS)

Arm Type

Active Comparator

Arm Description

Arm Title

Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)

Arm Type

Experimental

Arm Description

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 II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval debulking surgery

Arm Title

Arm III (carboplatin, paclitaxel, CRS, cisplatin)

Arm Type

Experimental

Arm Description

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 III: Patients receive cisplatin IV the day prior to interval debulking surgery

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Cytoreductive Surgery

Other Intervention Name(s)

Cytoreduction

Intervention Description

Undergo CRS

Intervention Type

Drug

Intervention Name(s)

Hyperthermic Intraperitoneal Chemotherapy

Other Intervention Name(s)

HIPEC

Intervention Description

Undergo HIPEC

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Incidence of chemotherapy-related adverse events

Description

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

Time Frame

Up to 30 days after perioperative treatment

Secondary Outcome Measure Information:

Title

Feasibility of chemotherapy immediately perioperatively

Description

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

Title

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

Description

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

Time Frame

Up to 1 year

Title

Recurrence free survival

Description

time between surgery and recurrence

Time Frame

For 3-5 years after study

Title

Tumor response

Description

tumor response evaluated per clinical standards

Time Frame

Up to 1 year

Title

Quality of life (QOL) assessment EORTC QLQ-C30

Description

Validated quality of life assessments

Time Frame

Baseline up to 6 months post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

The Ohio State University Comprehensive Cancer Center

Phone

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Floor Backes, MD

Organizational Affiliation

Ohio State University Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University Comprehensive Cancer Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Floor Backes, MD

Phone

614-209-3873

First Name & Middle Initial & Last Name & Degree

Floor Backes, MD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://cancer.osu.edu

Description

The Jamesline

Learn more about this trial

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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