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Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca

Primary Purpose

Ovarian Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyperthermia
Sponsored by
Mark Dewhirst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian, debulked, recurrent, Stage III, Stage IV

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Optimal debulking (< 1cm residual disease) of their disease within 6 weeks of the start of the study
  • Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
  • GOG performance status 0, 1, or 2
  • Patients must have normal organ and marrow function defined as:
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin and creatinine <1.5 X institutional upper limit of normal(ULN)
  • AST(SGOT)/ALT(SGPT)<3 X institutional ULN

Exclusion Criteria:

  • Patients with biochemical recurrences or evidence of measurable disease
  • Patients with suboptimal (>1 cm) residual disease
  • Patients who have had chemotherapy within 4 weeks prior
  • Receiving any investigational agents
  • Known brain metastases
  • Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
  • Uncontrolled intercurrent illness
  • Prior radiation therapy
  • History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Chemotherapy plus Hyperthermia

    Outcomes

    Primary Outcome Measures

    Toxicity

    Secondary Outcome Measures

    Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging

    Full Information

    First Posted
    November 6, 2008
    Last Updated
    November 10, 2014
    Sponsor
    Mark Dewhirst
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00787488
    Brief Title
    Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca
    Official Title
    A Pilot Study of Intravenous and Intraperitoneal Chemotherapy Plus Abdominal Hyperthermia to Treat Optimally Debulked and Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study not funded
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mark Dewhirst

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.
    Detailed Description
    Day 1 of each 21 day Cycle: Paclitaxel 175 mg/m2 IV (infused over 3 hours) Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the IP port. Cisplatin 75 mg/m2 reconstituted in 500 ml NS warmed to 37 degrees Celsius is infused IP (30 minute infusion)followed immediately by whole abdominal hyperthermia Abdominal hyperthermia will be delivered using the BSD 2000 ellipse system to target temperatures of 40-42 degrees Celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. Total duration of hyperthermia will be no greater than 90 minutes. Day 8: Paclitaxel 60 mg/m2 IP. Paclitaxel will be diluted and filtered initially in 1000 ml of normal saline or D5W warmed to 37 degrees Celsius. For IP administration, the patient must receive an additional 1000 ml of normal saline degrees Celsius in the peritoneal cavity. Cycles will be repeated every 3 weeks x 6 cycles. Patients will be followed until disease progression/recurrence or death.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer
    Keywords
    Ovarian, debulked, recurrent, Stage III, Stage IV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Chemotherapy plus Hyperthermia
    Intervention Type
    Device
    Intervention Name(s)
    Hyperthermia
    Intervention Description
    Every 3 weeks
    Primary Outcome Measure Information:
    Title
    Toxicity
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer Optimal debulking (< 1cm residual disease) of their disease within 6 weeks of the start of the study Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy GOG performance status 0, 1, or 2 Patients must have normal organ and marrow function defined as: absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin and creatinine <1.5 X institutional upper limit of normal(ULN) AST(SGOT)/ALT(SGPT)<3 X institutional ULN Exclusion Criteria: Patients with biochemical recurrences or evidence of measurable disease Patients with suboptimal (>1 cm) residual disease Patients who have had chemotherapy within 4 weeks prior Receiving any investigational agents Known brain metastases Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas) Uncontrolled intercurrent illness Prior radiation therapy History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Jewell, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Angeles Secord, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ellen Jones, MD, PhD
    Organizational Affiliation
    Duke University Medical Center, Radiation Oncology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca

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