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

NCT01083537 | Terminated Phase 1

• 1 other identifier: MBO-CHEMO-BSC
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

malignant bowel obstruction; ovarian cancer; Peritoneal cancer; Fallopian Tube cancer

Outcome Measures

Primary Outcomes (3)

• Overall Safety Profile

  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.

  Day 1 of treatment until resolution of symptoms

• Quality of Life Scores at Baseline, Day 30 and Day 90

  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.

  Day 1 of treatment until resolution of symptoms

• Time to Resolution of Bowel Obstruction

  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.

  Day 1 of treatment until resolution of symptoms

Secondary Outcomes (2)

• Survival

  30 days, 60 days, and 90 days from treatment start date

• Evaluation of Toxicity

  Time of consent until resolution of symptoms

Study Arms (2)

Cisplatin

EXPERIMENTAL

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

Paclitaxel

EXPERIMENTAL

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

Interventions

Cisplatin 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

Cisplatin

Paclitaxel 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

Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Intestinal Obstruction

Interventions

Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Amit Oza

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Nicole Chau

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 9, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CA (1)