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

This study is not yet open for participant recruitment.
Verified October 2013 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01970722
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

This clinical trial studies surgery and heated chemotherapy with or without non-heated chemotherapy after surgery in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, and gentamicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen during surgery and infusing heated and unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.


Condition Intervention
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Recurrent Primary Peritoneal Cavity Cancer
Recurrent Uterine Sarcoma
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIC Ovarian Germ Cell Tumor
Stage IIC Primary Peritoneal Cavity Cancer
Stage IIIA Endometrial Carcinoma
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIA Uterine Sarcoma
Stage IIIB Endometrial Carcinoma
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIB Uterine Sarcoma
Stage IIIC Endometrial Carcinoma
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Ovarian Germ Cell Tumor
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IIIC Uterine Sarcoma
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Stage IV Primary Peritoneal Cavity Cancer
Stage IVA Endometrial Carcinoma
Stage IVA Uterine Sarcoma
Stage IVB Endometrial Carcinoma
Stage IVB Uterine Sarcoma
Procedure: therapeutic conventional surgery
Drug: cisplatin
Drug: carboplatin
Drug: paclitaxel
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: gentamicin
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 12 months post-surgery ] [ Designated as safety issue: No ]
    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, assessed up to 3 years ] [ Designated as safety issue: No ]
    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.

  • OS defined as any death, cancer-related or not [ Time Frame: From the date of completion of treatment to the date of death, assessed up to 3 years ] [ Designated as safety issue: No ]
    OS 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: December 2013
Estimated Primary Completion Date: December 2019 (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 gentamicin 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: gentamicin
Given IP or IV
Other Names:
  • Garamicin
  • Garamycin
  • Genoptic
  • Genoptic S.O.P.
  • GM
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 estimate overall survival (OS). V. 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.

At least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gentamicin IP or intravenously (IV) at the discretion of the medical and gynecologic oncologists.

After completion of study treatment, patients are followed up at 2 and 6 weeks, every 3 months for 2 years, and then every 4 months for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with newly diagnosed or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage IIC-IIIC or IV ovarian, fallopian tube, peritoneal carcinoma, or stage III-IV uterine cancer, confined to abdominal cavity
  • Gynecologic Oncology Group (GOG) performance status =< 1
  • Patients who are platinum-sensitive
  • Candidate for potentially radical, maximal effort cytoreductive surgery indicated by a Peritoneal Cancer Index (PCI) of =< 25 determined by helical computed tomography (CT) scan +/- staging laparoscopy (at the discretion of the surgeon)
  • If the patient has 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
    • Resolution of ascites
    • 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 below
  • Hemoglobin (HGB) >= 9 g/dL
  • White blood cell count (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 Cockroft-Gault formula
  • Neuropathy (sensory and motor) NCI CTCAE grade =< 1
  • 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
  • Diagnosis of high-grade serous or undifferentiated carcinoma of ovarian, peritoneal, or fallopian tubal origin confirmed on intra-operative assessment
  • 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 who are platinum-resistant
  • Patients with extra-abdominal disease including malignant pleural effusion
  • 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 invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 2 years after completion of treatment), who had (or have) any evidence of other cancer present within the last 5 years
  • Metastatic non-gynecologic or breast primaries
  • Gynecologic malignancy of borderline histology
  • Sub-optimal resection as their surgical outcome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970722

Locations
United States, California
City of Hope Medical Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Thanh Dellinger    800-826-4673    tdellinger@coh.org   
Principal Investigator: Thanh Dellinger         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Thanh Dellinger City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01970722     History of Changes
Other Study ID Numbers: 12316, NCI-2013-01948, 12316, P30CA033572
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases
Neoplasms, Connective and Soft Tissue
Cisplatin
Doxorubicin

ClinicalTrials.gov processed this record on April 14, 2014