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

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ClinicalTrials.gov Identifier: NCT00889733
Recruitment Status : Terminated (Poor recruitment)
First Posted : April 29, 2009
Last Update Posted : October 7, 2011
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Drug: Intraperitoneal (IP) Cisplatin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2007
Primary Completion Date : July 2009

Intervention Details:
    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.

Primary Outcome Measures :
  1. Safety and Dose Tolerance [ Time Frame: Day 1 of each cycle and assessed every 3 months in follow-up (if applicable) ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889733

Canada, Ontario
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada

Responsible Party: Dr. Helen Mackay, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00889733     History of Changes
Other Study ID Numbers: OVHM-01
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action