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

NCT ID: NCT01083537

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-06-30

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.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer; Bowel Obstruction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Oza

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Nicole Chau

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MBO-CHEMO-BSC

Identifier Type: -

Identifier Source: org_study_id