Intraperitoneal (IP) Cisplatin Given With Paclitaxel to Treat Epithelial Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— OVHM-01  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00889733
• Other study ID #: OVHM-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Intraperitoneal (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.

Locations

Country	Name	City	State
Canada	University Health Network - Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Dose Tolerance		Day 1 of each cycle and assessed every 3 months in follow-up (if applicable)
Secondary	Time to progression		Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted