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TerminatedNCT00889733OVHM-01Updated Mar 26, 2024

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

A Phase 1/2 interventional study of Intraperitoneal (IP) Cisplatin in Epithelial Ovarian Cancer, sponsored by University Health Network, Toronto. Terminated at 1 site in Canada. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by University Health Network, Toronto · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Poor recruitment
Phase
Phase 1/2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

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Conditions studied

  • Epithelial Ovarian Cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts 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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    IP Cisplatin

    Patients with epithelial ovarian cancer who have undergone optimal debulking surgery receive IP Cisplatin with IV Paclitaxel.

    Drug: Intraperitoneal (IP) Cisplatin

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.

06

What researchers measure

Primary outcomes

  1. Safety and Dose Tolerance

    Time frame: Day 1 of each cycle and assessed every 3 months in follow-up (if applicable)

Secondary outcomes

  1. Time to progression

    Time frame: Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted

07

Study locations

1 site
  • University Health Network - Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00889733
Lead sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
Responsible party
Sponsor
First posted
Apr 29, 2009
Start date
Feb 2007
Primary completion
Jul 2009
Completion
Dec 2009
Last update
Mar 26, 2024

Study contacts

Helen MacKay, MD
principal investigator · UHN - Princess Margaret Cancer Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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