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

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Albumin-Bound Paclitaxel; BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Paclitaxel; Prochlorperazine

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.