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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01083537
First received: March 1, 2010
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Bowel Obstruction
Drug: Cisplatin
Drug: Paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall Safety Profile [ Time Frame: Day 1 of treatment until resolution of symptoms ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days, 60 days, and 90 days from treatment start date ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    All patients will be evaluable for toxicity from the time they sign consent.


Enrollment: 1
Study Start Date: February 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin

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
Drug: Cisplatin

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
Experimental: Paclitaxel

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
Drug: Paclitaxel

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01083537

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Amit Oza Princess Margaret Hospital, Canada
Principal Investigator: Nicole Chau Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Dr. Amit Oza, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT01083537     History of Changes
Other Study ID Numbers: MBO-CHEMO-BSC
Study First Received: March 1, 2010
Last Updated: June 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
malignant bowel obstruction
ovarian cancer
Peritoneal cancer
Fallopian Tube cancer

Additional relevant MeSH terms:
Intestinal Obstruction
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Peritoneal Diseases
Fallopian Tube Diseases
Cisplatin
Dexamethasone
Paclitaxel
Prochlorperazine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014