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

This study is currently recruiting participants.
Verified October 2017 by City of Hope Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970722
First Posted: October 28, 2013
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
  Purpose
This clinical 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.

Condition Intervention
Recurrent Uterine Corpus Cancer Recurrent Fallopian Tube Cancer Recurrent Ovarian Cancer Recurrent Primary Peritoneal Cancer Stage IIIA Uterine Corpus Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Cancer Stage IIIA Primary Peritoneal Cavity Cancer Stage IIIB Uterine Corpus Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Cancer Stage IIIB Primary Peritoneal Cavity Cancer Stage IIIC Uterine Corpus Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IIIC Primary Peritoneal Cavity Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cavity Cancer Stage IVA Uterine Corpus Cancer Stage IVB Uterine Corpus Cancer Procedure: therapeutic conventional surgery Drug: cisplatin Drug: carboplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Treatment-related toxicities according to NCI CTCAE guidelines [ Time Frame: Up to 3 months post-surgery ]
    Toxicity for both primary and recurrent groups will be summarized using frequency tables.


Secondary Outcome Measures:
  • QoL assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire [ Time Frame: Up to 15 months post-surgery ]
    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 IP chemotherapy for women with ovarian cancer.

  • PFS [ Time Frame: Time-of-study entry to time-of-detection of new lesions on CT imaging that is triggered by cancer antigen 125 (CA125) progression as defined by Gynecologic Cancer Intergroup Criteria (GCIG) or clinical symptoms or deterioration, assessed up to 3 years ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (surgery, HIPEC cisplatin)

Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (IP) over 60 minutes.

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.

Procedure: therapeutic conventional surgery
Undergo surgery
Drug: cisplatin
Given IP
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: carboplatin
Given IP or IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Given IP or IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: pegylated liposomal doxorubicin hydrochloride
Given IP or IV
Other Names:
  • CAELYX
  • Dox-SL
  • DOXIL
  • doxorubicin hydrochloride liposome
  • LipoDox
Drug: gemcitabine hydrochloride
Given IP or IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

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 and micro ribonucleic acid (RNA) profiling of ovarian cancer and ex vivo evaluation of oncolytic virus replication.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provided informed consent
  • Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV 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 (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 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 2 years 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970722


Contacts
Contact: Kathleen Kelly 626 256-4673 ext 60076 kkelly@coh.org

Locations
United States, California
City of Hope Corona Recruiting
Corona, California, United States, 92879
Contact: Cheryl Corpus    626-256-4673 ext 81529      
Contact: Misagh Karimi, MD    626-256-4673      
Principal Investigator: Misagh Karimi, MD         
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Thanh Dellinger    800-826-4673      
Principal Investigator: Thanh Dellinger         
City of Hope Rancho Cucamonga Recruiting
Rancho Cucamonga, California, United States, 91730
Contact: Valerie Estala    626-256-4673 ext 81699      
Principal Investigator: Behnam Ebrahimi, MD         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thanh Dellinger City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01970722     History of Changes
Other Study ID Numbers: 12316
NCI-2013-01948 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
12316 ( Other Identifier: City of Hope Medical Center )
First Submitted: October 23, 2013
First Posted: October 28, 2013
Last Update Posted: October 24, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Uterine Diseases
Paclitaxel
Gemcitabine
Liposomal doxorubicin
Cisplatin
Carboplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents