Status:
TERMINATED
Intraperitoneal (IP) Cisplatin Given With Paclitaxel to Treat Epithelial Ovarian Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
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 neoadj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00889733
Start Date
February 1 2007
End Date
December 1 2009
Last Update
March 26 2024
Active Locations (1)
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1
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9