Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

NCT05659381 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: GOG-3068217908
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 59

Brief Summary

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Stage III Primary Peritoneal Cancer; Stage IV Primary Peritoneal Cancer; Stage III Fallopian Tube Cancer; Stage IV Fallopian Tube Cancer

Keywords

HIPEC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression free survival in patients who receive a single treatment of intraoperative HIPEC with cisplatin vs. those who do not receive intraoperative HIPEC with cisplatin.

  From enrollment until time of disease progression or death, whichever occurs first, or date of last contact if neither progression of death has occurred, assessed up to 8 years

Secondary Outcomes (3)

• Overall Survival

  From enrollment to the time of death or date of last contact, assessed up to 8 years

• Frequency and severity of adverse events

  Every 28 days up to 3 years

• Progression Free Survival

  From the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years

Study Arms (2)

HIPEC

EXPERIMENTAL

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cisplatin 100 mg/m2 IP over 90 minutes at 42 degrees C

Drug: Cisplatin

No HIPEC

ACTIVE COMPARATOR

No treatment

Other: No treatment

Interventions

No treatment OTHER

No treatment with Cisplatin

No HIPEC

Cisplatin DRUG

Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius

Also known as: Platinol AQ

HIPEC

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a pathologic diagnosis of high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, FIGO stage III or IV documented on CT scan/MRI, must be recommended and agree to undergo platinum-based neoadjuvant chemotherapy with or without physician choice bevacizumab (3-4 cycles allowed, with bevacizumab held for at least 28 days preoperatively) and are considered candidates for (and planned to have) interval cytoreductive surgery (iCRS) followed by chemotherapy and niraparib maintenance as determined by the enrolling investigator. Patients may continue bevacizumab after a minimum of 28 days post iCRS and during niraparib maintenance per local standard.
• Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) or be deemed resectable with iCRS.
• Patients must have HRD/LOH positive tumors. Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not required to have HRD/LOH testing. Patients without BRCA or germline mutations must have HRD/LOH testing using Myriad myChoice®/Foundation Medicine/Caris Life Sciences platforms. HRD test results must be available prior to registration to meet entry criteria.
• Patients must have R0 (no gross/visible residual disease) or R1 (gross/visible residual disease ≤ 1.0 cm in the longest diameter) following iCRS and prior to randomization.
• Patient must have adequate bone marrow and organ function:
• Bone marrow function:
• Hemoglobin ≥ 8.5 g/dL. Absolute neutrophil count (ANC) ≥ 1,500/mm3. Platelets ≥ 100,000/mm3.
• Renal function:
• Creatinine ≤ 1.3mg/dl OR Calculated creatinine clearance (≥ 30 mL/min/1.73 m2) per National Kidney Foundation guidelines and NHANES III
• Hepatic function:
• Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN.
• Neurologic function:
• Peripheral neuropathy ≤ CTC AE grade 2.
• Patients must have an ECOG performance status of 0 or 1.
• Patient must be age \> 18.

You may not qualify if:

• Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors.
• Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy. Prior neoadjuvant treatment with bevacizumab is allowed; bevacizumab must be held for 28 days prior to surgery.
• Patients whose tumors are HRD/LOH negative.
• Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan/MRI required within 35 days of iCRS).
• Patients not eligible for iCRS based on medical co-morbidities as per the enrolling investigator.
• Patients with stage IV disease without complete response of extra-abdominal disease on preoperative findings (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, mesemchymal liver metastases or other extra-abdominal metastases) who are not deemed resectable with iCRS.
• Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.
• Patients who are pregnant or lactating.
• Patients with a severe infection requiring IV antibiotics within 2 weeks of planned randomization.
• Patients with other uncontrolled, intercurrent medical conditions.
• Patient with metastatic disease to the central nervous system.
• Patient with uncontrolled insulin dependent diabetes or pre-existing renal condition.
• Patients with pre-existing hearing loss related to prior platinum-based chemotherapy.
• Patients with Prior Reversible Encephalopathy Syndrome (PRES).
• Patients with current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). Severe hepatic impairment patients should be excluded.

Sponsors & Collaborators

• GOG Foundation: lead
• GlaxoSmithKline: collaborator

Study Sites (59)

City of Hope

Duarte, California, 91010, United States

RECRUITING

University of California San Diego Moores Cancer Center

La Jolla, California, 92037, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Stanford Ambulatory Surgery Center Lane Operating Room

Palo Alto, California, 94034, United States

RECRUITING

Stanford Women's Cancer Center

Palo Alto, California, 94304, United States

RECRUITING

Stanford Hospital

Palo Alto, California, 94305, United States

RECRUITING

University of Colorado Hospital - Anshutz Cancer Pavilion

Aurora, Colorado, 80045, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Smilow Cancer Hospital at Yale- New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

RECRUITING

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, 33146, United States

RECRUITING

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

RECRUITING

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, 33324, United States

RECRUITING

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Medical Center MOB

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Cancer Center Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

University of Kansas Indian Creek Breast Surgery

Overland Park, Kansas, 66211, United States

RECRUITING

University of Kansas Cancer Center Westwood

Westwood, Kansas, 66205, United States

RECRUITING

University of Kansas Clinical Research Center

Westwood, Kansas, 66205, United States

RECRUITING

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

LSU Health New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Missouri, 64116, United States

RECRUITING

University of Kansas Cancer Center North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

RECRUITING

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States

RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

UH Geauga Medical Center

Chardon, Ohio, 44024, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

TriHealth Cancer Institute - Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

RECRUITING

TriHealth Cancer Institute- Thomas Comprehensive Care Center

Cincinnati, Ohio, 45242, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

SCC at Lake University

Mentor, Ohio, 44060, United States

RECRUITING

UH Minoff Health Center at Chagrin Highlands

Orange, Ohio, 44122, United States

RECRUITING

West Chester Hospital

West Chester, Ohio, 45069, United States

RECRUITING

St. John Medical Center

Westlake, Ohio, 44145, United States

RECRUITING

Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025, United States

RECRUITING

Forbes Hospital

Monroeville, Pennsylvania, 15146, United States

RECRUITING

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Wexford Hospital

Wexford, Pennsylvania, 15090, United States

RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

Lankenau Medical Center/Mainline Medical Center

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Medical University of South Carolina (Hollings Cancer Center)

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Oncology - Central South

Austin, Texas, 78758, United States

RECRUITING

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

RECRUITING

O'Quinn Medical Tower at McNair Campus

Houston, Texas, 77054, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Leslie Randall, MD

  GOG Foundation

  STUDY CHAIR

Central Study Contacts

Sarin Chhab

CONTACT

215-854-0770; schhab@gog.org

Shanon Matkin

CONTACT

801-661-1584; smatkin@gog.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: March 8, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2034
• Last Updated: April 16, 2026

Record last verified: 2025-12

Locations

US (59)