Epithelial Ovarian Cancer
Conditions
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.
Interventions
DRUGIntraperitoneal (IP) Cisplatin
For patients who have had neoadjuvant chemotherapy followed by optimal debulking surgery they go on to receive combined IP Cisplatin and IV Paclitaxel.
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Dose Tolerance | Day 1 of each cycle and assessed every 3 months in follow-up (if applicable) |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted |
Countries
Canada
Outcome results
None listed