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

University Health Network, Toronto1 site in 1 country9 target enrollmentFebruary 2007

ConditionsEpithelial Ovarian Cancer

InterventionsIntraperitoneal (IP) Cisplatin

DrugsIntraperitoneal (IP) Cisplatin

Overview

Phase: Phase 1
Intervention: Intraperitoneal (IP) Cisplatin
Conditions: Epithelial Ovarian Cancer
Sponsor: University Health Network, Toronto
Enrollment: 9
Locations: 1
Primary Endpoint: Safety and Dose Tolerance
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether intraperitoneal (IP) Cisplatin combined with intravenous (IV) Paclitaxel is well tolerated in women with epithelial ovarian cancer who have had neoadjuvant chemotherapy followed by initial debulking surgery.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

December 2009

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

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.