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Intraperitoneal (IP) Cisplatin Given With Paclitaxel to Treat Epithelial Ovarian Cancer (OVHM-01)

Primary Purpose

Epithelial Ovarian Cancer

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Intraperitoneal (IP) Cisplatin
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Health Network - Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Safety and Dose Tolerance

Secondary Outcome Measures

Time to progression

Full Information

First Posted
April 27, 2009
Last Updated
October 6, 2011
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00889733
Brief Title
Intraperitoneal (IP) Cisplatin Given With Paclitaxel to Treat Epithelial Ovarian Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intraperitoneal (IP) Cisplatin
Intervention Description
For patients who have had neoadjuvant chemotherapy followed by optimal debulking surgery they go on to receive combined IP Cisplatin and IV Paclitaxel.
Primary Outcome Measure Information:
Title
Safety and Dose Tolerance
Time Frame
Day 1 of each cycle and assessed every 3 months in follow-up (if applicable)
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Health Network - Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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