Clinical trial NCT00889733: Intraperitoneal (IP) Cisplatin Given With Paclitaxel to Treat Epithelial Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Epithelial Ovarian Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2009-04-29
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety and Dose Tolerance
timeFrame: Day 1 of each cycle and assessed every 3 months in follow-up (if applicable)
Secondary outcomes:
measure: Time to progression
timeFrame: Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: UHN - Princess Margaret Cancer Centre
name: Helen MacKay, MD
role: PRINCIPAL_INVESTIGATOR
References: