The best way to treat MBO in patients with ovarian cancer has not been studied enough by trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive care approaches) affects clinical outcomes like resolution of bowel obstruction, survival, and quality of life. To improve patient outcomes, we must assess which patients will do better with palliative surgery, chemotherapy, or best supportive care. This study will gather safety information, and how reasonable it is to give chemotherapy and BSC to patients with advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look into the effects of chemotherapy and BSC on the quality of life and resolution of bowel obstruction, in hopes to perform future studies that lead to the best management of MBO.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1\) Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles. 1. Hesketh Level 5: 5HT3 receptor antagonist IV/po 30-60 mins pre-chemo and Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; Dexamethasone 4-8mg po BID x 3 days starting 24hours post last dose of chemo; Prochlorperazine 10mg po/IV q4-6h prn, metoclopramide 10-20mg po/iv q6h prn, haloperidol 0.5-2mg po/SC q 8-12 h prn 2. Hydration: Pre-hydration 500-1000cc NS with 10Meq KCl over 2 hours; Infuse Cisplatin in 250-500cc NS over 1 hour; Post-hydration 1000cc NS + 20Meq KCl (+/- 2g MgSO4) over 1 hour
2\) Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles. 1. Suggested prophylaxis for paclitaxel-associated hypersensitivity reactions: Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; diphenydramine 25-50mg IV 30-60 minutes pre-chemo, ranitidine 50mg IV 30-60 minutes pre-chemo 2. Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn 3. Hydration: Infuse Paclitaxel in 250cc NS over 1 hour
Princess Margaret Hospital
Toronto, Ontario, Canada
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.
Time frame: Day 1 of treatment until resolution of symptoms
Quality of Life Scores at Baseline, Day 30 and Day 90
Quality of life scores will be tabulated using counts and summary statistics. We hypothesize that at 30 days from treatment, there may be no improvement in quality of life scores compared to baseline. We hypothesize that at 90 days from treatment, there will be an improvement in quality of life scores from baseline by one third standard deviation. Paired T test and Mixed model will be used to make the comparison over different time period.
Time frame: Day 1 of treatment until resolution of symptoms
Time to Resolution of Bowel Obstruction
Time to resolution of bowel obstruction and time to recurrence of bowel obstruction will be assessed using summary statistics including mean, median, counts and proportion, to summarize the patients.
Time frame: Day 1 of treatment until resolution of symptoms
Survival
Survival: 30-day(all cause and disease-specific), 60-day(all cause and disease-specific), and 90-day mortality (all cause and disease-specific). Summary statistics will be used to summarize the patients. Survival estimates will be computed using Kaplan-Meier method. Variable association will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses. Non-parametric tests may be substituted if necessary. Results will be illustrated using figures and plots using 95 percent confidence intervals.
Time frame: 30 days, 60 days, and 90 days from treatment start date
Evaluation of Toxicity
All patients will be evaluable for toxicity from the time they sign consent.
Time frame: Time of consent until resolution of symptoms
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