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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

Primary Purpose

Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cisplatin
Paclitaxel
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring malignant bowel obstruction, ovarian cancer, Peritoneal cancer, Fallopian Tube cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospital admission and diagnosis compatible with Malignant Bowel Obstruction, as defined below:

    1. A diagnosis of primary ovarian cancer, primary peritoneal cancer or fallopian tube cancer
    2. At least two of the following four symptoms: (a) vomiting (>2 episodes in past 24 hours), (b) abdominal pain, (c) not passing gas per rectum in past 24 hours, (d) severe constipation (no bowel movement >24 hours).
    3. CT findings suggestive of complete bowel obstruction. CT Abdomen: confirms diagnosis of bowel obstruction (93% sensitivity 93-100% specificity) and aids in determining the location and etiology of obstruction.
  • Non-surgical candidate
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must be 18 years of age or older.
  • ECOG performance status 0, 1 or 2 (Karnofsky > or = 60%) one week prior to admission.
  • Patients must have adequate hematological function as defined below:
  • Absolute granulocyte count > or = 1.5 x 10^9/L
  • Platelet count > or = 100 x 10^9/L
  • Patients must have adequate renal and hepatic function as defined below:
  • Serum creatinine < or = 1.5 x ULN OR a calculated creatinine clearance > or = 50 ml/min
  • Bilirubin < or = 3 x ULN, AST < or = 5 x ULN, ALT < or = 5 x ULN

Exclusion Criteria:

  • Patients diagnosed with MBO caused by malignancy other than primary ovarian cancer.
  • Patients diagnosed with MBO who are surgical candidates.
  • Patients who are pregnant or breast-feeding.
  • Concomitant diagnosis of GI malignancy (platinum ineffective) within past 5 years.
  • History of severe hypersensitivity reaction to Cisplatin and Paclitaxel.
  • Patients who have received chemotherapy within 2 weeks prior to study enrollment.
  • Patients with uncontrolled Inflammatory Bowel Disease.
  • Patients with concurrent active infections with Clostridium Difficile.
  • Early postoperative obstruction (within 30 days from previous operation).
  • Patients who have had bowel irradiation within 6 weeks.
  • Patients with any of the following conditions are excluded:
  • Myocardial infarction within 6 months prior to entry.
  • Congestive heart failure.
  • Unstable angina.
  • Active cardiomyopathy.
  • Unstable ventricular arrhythmia.
  • Uncontrolled hypertension.
  • Uncontrolled psychotic disorders.
  • Serious infections.
  • Active peptic ulcer disease.
  • Uncontrolled psychiatric illness.
  • Any other medical conditions that might be aggravated by treatment or limit compliance.

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cisplatin

Paclitaxel

Arm Description

Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles. 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 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

Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles. 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 Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn Hydration: Infuse Paclitaxel in 250cc NS over 1 hour

Outcomes

Primary Outcome Measures

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.
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 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.

Secondary Outcome Measures

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.
Evaluation of Toxicity
All patients will be evaluable for toxicity from the time they sign consent.

Full Information

First Posted
March 1, 2010
Last Updated
February 13, 2019
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01083537
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Bowel Obstruction
Keywords
malignant bowel obstruction, ovarian cancer, Peritoneal cancer, Fallopian Tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin
Arm Type
Experimental
Arm Description
Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles. 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 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
Arm Title
Paclitaxel
Arm Type
Experimental
Arm Description
Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles. 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 Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn Hydration: Infuse Paclitaxel in 250cc NS over 1 hour
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
1) Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles. 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 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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
2) Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles. 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 Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn Hydration: Infuse Paclitaxel in 250cc NS over 1 hour
Primary Outcome Measure Information:
Title
Overall Safety Profile
Description
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
Title
Quality of Life Scores at Baseline, Day 30 and Day 90
Description
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
Title
Time to Resolution of Bowel Obstruction
Description
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
Secondary Outcome Measure Information:
Title
Survival
Description
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
Title
Evaluation of Toxicity
Description
All patients will be evaluable for toxicity from the time they sign consent.
Time Frame
Time of consent until resolution of symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital admission and diagnosis compatible with Malignant Bowel Obstruction, as defined below: A diagnosis of primary ovarian cancer, primary peritoneal cancer or fallopian tube cancer At least two of the following four symptoms: (a) vomiting (>2 episodes in past 24 hours), (b) abdominal pain, (c) not passing gas per rectum in past 24 hours, (d) severe constipation (no bowel movement >24 hours). CT findings suggestive of complete bowel obstruction. CT Abdomen: confirms diagnosis of bowel obstruction (93% sensitivity 93-100% specificity) and aids in determining the location and etiology of obstruction. Non-surgical candidate Ability to understand and the willingness to sign a written informed consent document. Patients must be 18 years of age or older. ECOG performance status 0, 1 or 2 (Karnofsky > or = 60%) one week prior to admission. Patients must have adequate hematological function as defined below: Absolute granulocyte count > or = 1.5 x 10^9/L Platelet count > or = 100 x 10^9/L Patients must have adequate renal and hepatic function as defined below: Serum creatinine < or = 1.5 x ULN OR a calculated creatinine clearance > or = 50 ml/min Bilirubin < or = 3 x ULN, AST < or = 5 x ULN, ALT < or = 5 x ULN Exclusion Criteria: Patients diagnosed with MBO caused by malignancy other than primary ovarian cancer. Patients diagnosed with MBO who are surgical candidates. Patients who are pregnant or breast-feeding. Concomitant diagnosis of GI malignancy (platinum ineffective) within past 5 years. History of severe hypersensitivity reaction to Cisplatin and Paclitaxel. Patients who have received chemotherapy within 2 weeks prior to study enrollment. Patients with uncontrolled Inflammatory Bowel Disease. Patients with concurrent active infections with Clostridium Difficile. Early postoperative obstruction (within 30 days from previous operation). Patients who have had bowel irradiation within 6 weeks. Patients with any of the following conditions are excluded: Myocardial infarction within 6 months prior to entry. Congestive heart failure. Unstable angina. Active cardiomyopathy. Unstable ventricular arrhythmia. Uncontrolled hypertension. Uncontrolled psychotic disorders. Serious infections. Active peptic ulcer disease. Uncontrolled psychiatric illness. Any other medical conditions that might be aggravated by treatment or limit compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Oza
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole Chau
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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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