Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction
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|ClinicalTrials.gov Identifier: NCT01083537|
Recruitment Status : Terminated (Slow accrual)
First Posted : March 9, 2010
Last Update Posted : June 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Bowel Obstruction||Drug: Cisplatin Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
U.S. FDA Resources
Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles.
1) Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles.
Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles.
2) Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles.
- Overall Safety Profile [ Time Frame: Day 1 of treatment until resolution of symptoms ]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.
- Quality of Life [ Time Frame: Day 1 of treatment until resolution of symptoms ]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 to Resolution of Bowel Obstruction [ Time Frame: Day 1 of treatment until resolution of symptoms ]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.
- Survival [ Time Frame: 30 days, 60 days, and 90 days from treatment start date ]
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.
- Evaluation of Toxicity [ Time Frame: Time of consent until resolution of symptoms ]All patients will be evaluable for toxicity from the time they sign consent.
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): NCT01083537
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza||Princess Margaret Hospital, Canada|
|Principal Investigator:||Nicole Chau||Princess Margaret Hospital, Canada|