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

This study has been withdrawn prior to enrollment.
(Study not funded)
Sponsor:
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00787488
First received: November 6, 2008
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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 Intervention
Ovarian Cancer
Device: Hyperthermia

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chemotherapy plus Hyperthermia
Device: Hyperthermia
Every 3 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787488

Sponsors and Collaborators
Mark Dewhirst
Investigators
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
  More Information

No publications provided

Responsible Party: Mark Dewhirst, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00787488     History of Changes
Other Study ID Numbers: Pro00008510
Study First Received: November 6, 2008
Last Updated: November 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Ovarian
debulked
recurrent
Stage III
Stage IV

Additional relevant MeSH terms:
Fever
Ovarian Neoplasms
Adnexal Diseases
Body Temperature Changes
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Signs and Symptoms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014