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A Phase I Study of Intraperitoneal Hyperthermic Docetaxel at the Time of Second Look Surgery Following Front-Line Normothermic Intraperitoneal and Intravenous Cisplatin/Paclitaxel for Patients With Stage II and III Ovarian Carcinoma


Phase 1
19 Years
N/A
Not Enrolling
Female
Ovarian Carcinoma

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Trial Information

A Phase I Study of Intraperitoneal Hyperthermic Docetaxel at the Time of Second Look Surgery Following Front-Line Normothermic Intraperitoneal and Intravenous Cisplatin/Paclitaxel for Patients With Stage II and III Ovarian Carcinoma


This is a phase I study of intraperitoneal hyperthermic docetaxel given at the time of
second look surgery following front-line normothermic intraperitoneal and intravenous
cisplatin/paclitaxel for patients with stage II and III ovarian carcinoma. The primary
objectives are to assess the maximum tolerated dose of docetaxel administered
intraperitoneally with heat at this time and assess the toxicity and morbidity associated
with this treatment. Eligible patients will have had a complete clinical response to
front-line therapy.


Inclusion Criteria:



- Patients must have had a complete clinical response (negative clinical examination,
CA125 and CT scan of chest, abdomen and pelvis) to front-line therapy for stage
II/III ovarian, primary peritoneal or Fallopian tube carcinoma. This will have
included initial surgery followed by combined IV/IP chemotherapy with cisplatin and
paclitaxel. Patients must have had a minimum of three courses of IP therapy with both
paclitaxel and cisplatin

- Second surgery to be performed no more than 3 months from last course of initial
chemotherapy

- Age greater than 18 years and negative pregnancy if has child-bearing potential

- GOG performance status less than 2

- Medically fit for surgery

- Patients must have normal organ and marrow function as defined in the protocol
hepatic function Total Bilirubin ULN AST and ALT and Alkaline Phosphatase must be
within the range allowing for eligibility. In determining eligibility the more
abnormal of the two values AST or ALT) should be used.

- Ability to understand and the willingness to sign a written informed consent
document.

- The effects of docetaxel on the developing human fetus are unknown. For this reason
and because taxanes are known to be teratogenic, women of child-bearing potential
must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

- Patients who have completed front-line therapy for ovarian cancer more than 3 months
prior to HIPEC.

- Patients receiving any other investigational agents.

- Patients with stage IV disease including previous parenchymal liver disease, brain
metastasis or cytologically-confirmed chest metastasis

- Patients with a history of severe hypersensitivity reaction to Taxotere® or other
drugs formulated with polysorbate 80. History of allergic reactions attributed to
compounds of similar chemical or biologic composition used in this study in addition
to Taxotere.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- More than grade 2 peripheral neuropathy from prior chemotherapy

- Pregnant, breast-feeding or known to be HIV positive

- Prior malignancy other than non-melanomatous skin cancer more than 5 years ago

- No prior chemotherapy other than for front-line ovarian cancer or radiation for any
reason.

- Stomatitis of any grade

- Uncontrolled intercurrent illness or other conditions that would limit compliance
with study requirements should be excluded.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel.

Outcome Time Frame:

6 months-5 years

Safety Issue:

Yes

Principal Investigator

C. William Helm, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

BCC-GYN-07-001

NCT ID:

NCT00474669

Start Date:

June 2007

Completion Date:

December 2009

Related Keywords:

  • Ovarian Carcinoma
  • Ovarian Carcinoma
  • Carcinoma
  • Fever
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202