FIGO Stage IVA Ovarian CancerPhase 1NCT01970722

Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer

A Phase 1 study testing Carboplatin, Cisplatin and Gemcitabine Hydrochloride in people with FIGO Stage IVA Ovarian Cancer and FIGO Stage IVB Ovarian Cancer, run by City of Hope Medical Center at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer, Platinum-Resistant Ovarian Carcinoma
What is being tested?: Carboplatin, Cisplatin and Gemcitabine Hydrochloride
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesUnited States
Study dates: 19 May 2014to 5 Jan 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 25Show fewer

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

City of Hope Corona
Corona, California, 92879
City of Hope Medical Center
Duarte, California, 91010
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
City of Hope Upland
Upland, California, 91786

Other trials in United States

About this study

Official title: Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin

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.

Read the detailed description

PRIMARY OBJECTIVE:

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:

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: FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer, Platinum-Resistant Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Being tested: Carboplatin, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel
Medical subject headings: Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IP or IV
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IP
Gemcitabine HydrochlorideDrug
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832
Given IP or IV
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IP or IV
Pegylated Liposomal Doxorubicin HydrochlorideDrug
Also called ATI-0918, Caelyx, DOX-SL, Doxil
Given IP or IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery

Study groups in NCT01970722
Study group	Role	What they receive
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. Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin Hydrochloride; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The FACT-O has four subscales: physical, social/family, emotional, and functional well-being. Answers are on a scale of 0 'not at all' to 4 'very much'. To estimate effect sizes over time, generalized linear models will be used to estimate the correlations between potential prognostic factors. Generalized estimating equations (GEEs) have utility in modeling longitudinal effects across time in prospective cohorts, and the models will include time-dependent covariate structures for continuous outcomes. QoL will be compared to a historical control of intraperitoneal (IP) chemotherapy for women with ovarian cancer.
Measured: Up to 15 months post-surgery
Progression-free survival (PFS)
PFS will be estimated in both groups. The survival curve will be estimated using Kaplan-Meier method and graphically displayed along with the corresponding 95% confidence curves. The Cox proportional hazards model will be used to derive an estimate of the hazard ratio and its corresponding 95% confidence limits.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 20145 Jan 2027

First posted28 Oct 2013 (estimated)
Study start19 May 2014
Primary completion5 Jan 2027 (estimated)
Study completion5 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FIGO Stage IVA Ovarian CancerStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970722
Sponsor's protocol ID: 12316
Other IDs: NCI-2013-01948, 122550, 108303, 116613, 122035, 12316
Status last verified: Mar 2026
First submitted: 23 Oct 2013
Last updated: 5 Mar 2026
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 35357903