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

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. Read our disclaimer for details. Identifier: NCT00787488
Recruitment Status : Withdrawn (Study not funded)
First Posted : November 7, 2008
Last Update Posted : November 11, 2014
Information provided by (Responsible Party):
Mark Dewhirst, Duke University

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Device: Hyperthermia Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: 1
Chemotherapy plus Hyperthermia
Device: Hyperthermia
Every 3 weeks

Primary Outcome Measures :
  1. Toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00787488

Sponsors and Collaborators
Mark Dewhirst
Principal Investigator: Elizabeth Jewell, MD Duke University
Principal Investigator: Angeles Secord, MD Duke University
Principal Investigator: Ellen Jones, MD, PhD Duke University Medical Center, Radiation Oncology

Responsible Party: Mark Dewhirst, Professor, Duke University Identifier: NCT00787488     History of Changes
Other Study ID Numbers: Pro00008510
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014

Keywords provided by Mark Dewhirst, Duke University:
Stage III
Stage IV

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms