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

This study has been terminated.
(Poor recruitment)
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00889733
First received: April 27, 2009
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Epithelial Ovarian Cancer
Drug: Intraperitoneal (IP) Cisplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2007
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889733

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

No publications provided

Responsible Party: Dr. Helen Mackay, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00889733     History of Changes
Other Study ID Numbers: OVHM-01
Study First Received: April 27, 2009
Last Updated: October 6, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014