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
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Overall Safety Profile
Secondary Outcome
Survival
Condition
Ovarian Cancer
Intervention
Cisplatin
Study Arms / Comparison Groups
Cisplatin
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
February 2010
Completion Date
June 2012
Primary Completion Date
June 2012
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amit Oza, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01083537
Organization ID
MBO-CHEMO-BSC
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Amit Oza, Principal Investigator, Princess Margaret Hospital, Canada
Verification Date
February 2019