Phase I/II Trial of Best Supportive Care and Chemotherapy, Either Cisplatin or Paclitaxel, in Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Presenting With Inoperable Malignant Bowel Obstruction
The optimal management of MBO in patients with ovarian cancer has not been defined by proper
prospective randomized control trials evaluating the impact of defined multidisciplinary
treatment arms (surgical, chemotherapeutic, supportive care approaches) on important
clinical outcomes including resolution of bowel obstruction, survival endpoints and
validated quality of life outcomes. In order to improve patient outcomes, we must define
which patients will benefit from palliative surgery, which patients are appropriate
candidates for chemotherapy and which patients will benefit most from best supportive care.
This study will determine the safety, feasibility of chemotherapy and BSC in patients with
advanced ovarian cancer presenting with MBO who are initially deemed non-surgical candidates
and will identify the impact of chemotherapy and BSC on quality of life and resolution of
bowel obstruction, in preparation for future prospective randomized studies to determine the
optimal management of MBO.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Safety Profile
Type, frequency, severity (NCI CTCAE v.3.0.1) and relationship to trial treatment of adverse events and laboratory abnormalities. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
Day 1 of treatment until resolution of symptoms
Princess Margaret Hospital, Canada
Canada: Health Canada