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A Phase I/II Trial of Intraperitoneal (IP) Cisplatin Combined With IV Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Their Initial Surgery Performed Following Neoadjuvant Intravenous Chemotherapy


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Female
Epithelial Ovarian Cancer

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Trial Information

A Phase I/II Trial of Intraperitoneal (IP) Cisplatin Combined With IV Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Their Initial Surgery Performed Following Neoadjuvant Intravenous Chemotherapy


Inclusion Criteria:



- Histologically proven epithelial ovarian cancer

- Previously received no more than 4 cycles of neoadjuvant platinum based chemotherapy,
followed by debulking surgery

- ECOG PFS <_ 2

- Adequate haematological (absolute neutrophil count >_ 1,500/mm3; platelets >_
100,000/mm3; hemoglobin >_ 100g/L); renal (<_ upper limit of normal) and hepatic
function

- Age >_ 18 years

- Written informed consent and the ability of the patient to co-operate with treatment
and follow up

Exclusion Criteria:

- Contraindication to platinum/Paclitaxel chemotherapy: prior anaphylaxis to
Carboplatin/Paclitaxel, unresolved or excessive toxicity from neoadjuvant
chemotherapy. Patients must not have suffered significant bone marrow suppression
during prior treatment. The significance of previous treatment delay and/or dose
modification is to be determined by the Principle Investigator on a
patient-by-patient basis.

- Serious concomitant medical condition, which in the investigators opinion would not
make the patient a good candidate for the clinical trial.

- Patients with a past or concomitant malignancy other than skin cancer (excluding
melanoma)

- Patients known to be serologically positive for Hepatitis B, C or HIV

- History of congestive heart failure or unstable angina or those who had a myocardial
infarction within the past 6 months. Patients who were not expected to tolerate the
hemodynamic effects of the fluid administered as part of the IP protocol.

- Patients who have not received chemotherapy prior to surgery

- Greater than 6 weeks from time of surgery to commencement of IP chemotherapy

- Residual disease greater than 1 cm at time of surgery. Patients whom in the
surgeon's opinion are candidates for such surgery may be consented preoperatively to
allow intraoperative IP catheter insertion. If however the surgeon is not able to
reduce the bulk of disease to less than or equal to 1 cm, patients will be removed
from the study and an IP catheter SHOULD NOT be placed.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and Dose Tolerance

Outcome Time Frame:

Day 1 of each cycle and assessed every 3 months in follow-up (if applicable)

Safety Issue:

Yes

Authority:

Canada: Ethics Review Committee

Study ID:

OVHM-01

NCT ID:

NCT00889733

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Epithelial Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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