NCT01970722

Brief Summary

This phase I trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
8mo left

Started May 2014

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2014Jan 2027

First Submitted

Initial submission to the registry

October 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

May 19, 2014

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

12.6 years

First QC Date

October 23, 2013

Last Update Submit

March 3, 2026

Conditions

FIGO Stage IVA Ovarian CancerFIGO Stage IVB Ovarian CancerPlatinum-Resistant Ovarian CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Uterine Corpus CarcinomaStage III Fallopian Tube Cancer AJCC v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Primary Peritoneal Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Stage IIIA Fallopian Tube Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIA Primary Peritoneal Cancer AJCC v7Stage IIIA Uterine Corpus Cancer AJCC v7Stage IIIB Fallopian Tube Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIB Primary Peritoneal Cancer AJCC v7Stage IIIB Uterine Corpus Cancer AJCC v7Stage IIIC Fallopian Tube Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IIIC Primary Peritoneal Cancer AJCC v7Stage IIIC Uterine Corpus Cancer AJCC v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7Stage IVA Uterine Corpus Cancer AJCC v7Stage IVB Uterine Corpus Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines

    Toxicity for both primary and recurrent groups will be summarized using frequency tables.

    Up to 3 months post-surgery

Secondary Outcomes (2)

  • Quality of life (QoL) assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire

    Up to 15 months post-surgery

  • Progression-free survival (PFS)

    From time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by CA125 progression as defined by Gynecologic Cancer Intergroup Criteria (GCIG) or clinical symptoms or deterioration, assessed up to 3 years

Study Arms (1)

Treatment (surgery, HIPEC cisplatin)

EXPERIMENTAL

Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.

Drug: CarboplatinDrug: CisplatinDrug: Gemcitabine HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PaclitaxelDrug: Pegylated Liposomal Doxorubicin HydrochlorideOther: Quality-of-Life AssessmentProcedure: Therapeutic Conventional Surgery

Interventions

CarboplatinDRUG

Given IP or IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Treatment (surgery, HIPEC cisplatin)
CisplatinDRUG

Given IP

Also known as: 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
Treatment (surgery, HIPEC cisplatin)
Gemcitabine HydrochlorideDRUG

Given IP or IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011
Treatment (surgery, HIPEC cisplatin)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (surgery, HIPEC cisplatin)
PaclitaxelDRUG

Given IP or IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Treatment (surgery, HIPEC cisplatin)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Treatment (surgery, HIPEC cisplatin)
Therapeutic Conventional SurgeryPROCEDURE

Undergo surgery

Treatment (surgery, HIPEC cisplatin)
Pegylated Liposomal Doxorubicin HydrochlorideDRUG

Given IP or IV

Also known as: ATI-0918, Caelyx, DOX-SL, Doxil, Doxilen, Doxorubicin HCl Liposomal, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Duomeisu, Evacet, LipoDox, Lipodox 50, Liposomal Adriamycin, liposomal doxorubicin hydrochloride, Liposomal-Encapsulated Doxorubicin, Pegylated Doxorubicin HCl Liposome, S-Liposomal Doxorubicin, Stealth Liposomal Doxorubicin, TLC D-99
Treatment (surgery, HIPEC cisplatin)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provided informed consent
  • Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
  • Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky scale (KPS) \>= 70%
  • Patients who are platinum-sensitive or platinum resistant
  • Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
  • For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:
  • Decline in serum cancer antigen (CA) 125 level
  • At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
  • Improvement of ascites volume
  • Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
  • Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =\< 1 and to baseline laboratory values as defined
  • Hemoglobin (HGB) \>= 9 g/dL
  • White blood cell (WBC) \>= 3,000/mcL
  • Absolute neutrophil count (ANC) \>= 1,500/mcL
  • Platelets (PLT) \>= 100,000/mcL
  • +10 more criteria

You may not qualify if:

  • Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
  • Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following:
  • Doubling of serum CA-125 level
  • At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
  • Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
  • Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
  • Patients whose circumstances do not permit completion of the study or the required follow-up
  • Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
  • Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment)
  • Metastatic non-gynecologic or breast primaries
  • Sub-optimal resection as their surgical outcome
  • Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

City of Hope Corona

Corona, California, 92879, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Upland

Upland, California, 91786, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

Related Publications (1)

  • Dellinger TH, Han ES, Raoof M, Lee B, Wu X, Cho H, He TF, Lee P, Razavi M, Liang WS, Schmolze D, Priceman SJ, Lee S, Lin WC, Lin JF, Kebria M, Hakim A, Ruel N, Stewart DB, Wang EW, Paz BI, Wakabayashi MT, Cristea MC, Rodriguez-Rodriguez L. Hyperthermic Intraperitoneal Chemotherapy-Induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer. JCO Precis Oncol. 2022 Mar;6:e2100239. doi: 10.1200/PO.21.00239.

    PMID: 35357903DERIVED

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian Neoplasms

Interventions

CarboplatinCisplatin1,2-diaminocyclohexaneplatinum II citratePlatinumGemcitabinePaclitaxelTaxesliposomal doxorubicinDoxorubicin

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMetals, HeavyElementsTransition ElementsMetalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Thanh Dellinger

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 28, 2013

Study Start

May 19, 2014

Primary Completion (Estimated)

January 5, 2027

Study Completion (Estimated)

January 5, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(4)