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
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
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
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.
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cisplatin
Paclitaxel
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