Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
NCT ID: NCT01970722
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2014-05-19
2026-02-03
Brief Summary
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Detailed Description
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I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.
SECONDARY OBJECTIVES:
I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer.
II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.
III. To estimate progression-free survival (PFS). IV. To collect biospecimens and perform correlative translational studies focused on understanding the mechanisms of action of HIPEC on ovarian cancer.
OUTLINE:
Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (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 intravenously (IV) at the discretion of the medical and gynecologic oncologists.
After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15 months; every 3 months for 1 year; and then every 4 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (surgery, HIPEC cisplatin)
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.
Carboplatin
Given IP or IV
Cisplatin
Given IP
Gemcitabine Hydrochloride
Given IP or IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IP or IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IP or IV
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
Undergo surgery
Interventions
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Carboplatin
Given IP or IV
Cisplatin
Given IP
Gemcitabine Hydrochloride
Given IP or IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IP or IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IP or IV
Quality-of-Life Assessment
Ancillary studies
Therapeutic Conventional Surgery
Undergo surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Total bilirubin within normal institutional limits
* Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN)
* Creatinine \< 1.5 x ULN or creatinine clearance \> 60 ml/min according to Cockcroft-Gault formula
* Neuropathy (sensory and motor) NCI CTCAE grade =\< 2
* Prothrombin time (PT) such that international normalized ratio (INR) is \< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) \< 1.2 times control
* Serum albumin \>= 2.5
* No active infection requiring antibiotics
* Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
* Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
* Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Thanh Dellinger
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Corona
Corona, California, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope Upland
Upland, California, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
Countries
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References
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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.
Other Identifiers
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NCI-2013-01948
Identifier Type: REGISTRY
Identifier Source: secondary_id
122550
Identifier Type: -
Identifier Source: secondary_id
108303
Identifier Type: -
Identifier Source: secondary_id
116613
Identifier Type: -
Identifier Source: secondary_id
122035
Identifier Type: -
Identifier Source: secondary_id
12316
Identifier Type: OTHER
Identifier Source: secondary_id
12316
Identifier Type: -
Identifier Source: org_study_id
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