Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in the First Recurren

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Pilot Study of Hyperthermic Intraperitoneal
Chemotherapy Utilizing Carboplatin in the First
Recurrence of Ovarian Cancer

• Primary Investigator
• Patricia Judson
• Co-Investigators
• Joseph Ivy
• Todd Tuttle

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Background

• 22,000 new cases in 2008
• Majority will see a response to primary C/T
• Recurrence rate of up to 75
• When the surgeons are able to remove all visible
  cancer, GOG studies have shown improved PFS and
  OS with the IP delivery of chemotherapy (GOG 104,
  111, 172)
• Studies performed in initial setting

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Background

• Why IP?
• Since OVCA is primarily an intra-abdominal
  disease, this exposes the tumor directly to the
  chemotherapy
• May also penetrate the tumor better
• Stays around longer in the abdomen/tumor
• Decreases systemic side effects
• Enhances chemotherapy anti-tumor effect?

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Background

• Why heated IP chemotherapy?
• The heat improves
• Chemotherapy absorption and penetration within
  tumor nodules
• Increases chemotherapy cytotoxic effects
• It appears that the heat is also lethal to tumor
  cells but not normal cells
• When combined with a secondary tumor reducing
  surgeryimprovements in PFS/OS were seen as
  compared to standard IV therapy

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Treatment Plan
Documented recurrence by 2 fold increase in CA125
or measurable disease on imaging study ? Meets
eligibility criteria for HIPC ? 10 patients
undergo HIPC ? 6 cycles of standard 2nd line
chemotherapy ? 3 month clinic visits with serial
CA125s, physical exams, and imaging as
clinically indicated with documentation of
PFS/OS/QOL
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What is the Goal of this Study?

• To determine the clinical response to patients
  treated with HIPC at the time of first clinical
  recurrence of EOC/PPC
• To monitor the toxicities associated with HIPC in
  this setting
• To determine treatment related QOL changes, if
  present
• To determine the overall feasibility of HIPC in
  the recurrent setting

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Whos Eligible?

• Known primary diagnosis of EOC/PPC
• First recurrence at least 6 months from end of
  primary treatment
• Good performance status
• Medically able to undergo secondary surgery
• Adequate BM and renal function

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Whos Not Eligible?

• Known disease outside of the abdominal cavity
• Recurrence prior to 6 months
• History of another cancer within the last 5 years
• History of acute sensitivity to platin
  chemotherapy

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Once Eligible, What Happens Then?

• Recurrence determined by
• 2 fold increase in CA125 or
• Measurable disease on a CT
• Will undergo Hyperthermic IntraPeritoneal
  Chemotherapy (HIPC)

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HIPC

• This is a surgical procedure in which the you
  will undergo a secondary debulking procedure
• All visible tumor will be removed
• All adhesions will be taken down
• 2 inflow ports will be placed in the upper
  abdomen
• 2 outflow ports will be placed in the lower
  abdomen
• Temperature probes will be used in the esophagus
  and bladder to monitor core body temperature
• The chemotherapy will be infused at a temperature
  of 40-42 C (105-110 F) for 90 minutes at a rate
  of 1-1.5L/minute
• Carboplatin is used for its decreased toxicity
  profile as compared to cisplatin

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HIPC
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After HIPC?

• Recovery will be similar to the recovery needed
  after your primary surgery
• Once fully recovered and within 6 weeks of the
  HIPC procedure
• you will begin the standard 6 cycles of IV
  chemotherapy consisting of Carbo/Taxol
• Remainder of care is unchanged
• Exams, CA125s, imaging, etc

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What Will Be Monitored During the Follow-up?

• We will monitor you for complete response,
  disease free timing and overall survival
• CA125s and imaging will be used to determine
  each interval
• We will monitor performance status throughout
  study
• You will be asked to complete a QOL questionnaire
  during each visit
• All toxicities will be documented

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Conclusions

• We hope to find in this pilot study that it is
  feasible to use HIPC in the recurrent setting
• We hope to see a prolonged disease free interval,
  longer intervals between treatments and improved
  overall survival as well as quality of life