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AzTrials

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
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, Cisplatin and Gemcitabine Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesUnited States
Study dates
1 Jul 2014to 5 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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:
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  • 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
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  • 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:

  1. 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:

  1. 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.

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 groupRoleWhat they receive
Treatment (surgery, HIPEC cisplatin)ExperimentalPatients 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.

  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.

    Measured: Up to 3 months post-surgery

Secondary outcomes (2)

  1. 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

  2. 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.

  1. First posted28 Oct 2013 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion5 Jan 2027 (estimated)
  4. Study completion5 Jan 2027 (estimated)

Resources

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
Oct 2026
First submitted
23 Oct 2013
Last updated
26 Oct 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines (time frame: Up to 3 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01970722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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