Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Intestinal Obstruction

Carcinoma

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Intestinal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Dyskinesia Agents

Central Nervous System Depressants

Psychotropic Drugs

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Anticonvulsants

Reproductive Control Agents

Paclitaxel

Albumin-Bound Paclitaxel

Dexamethasone

Haloperidol

Haloperidol decanoate

Magnesium Sulfate

Cisplatin

Dexamethasone acetate

Metoclopramide

Prochlorperazine

Serotonin

Ranitidine

Ranitidine bismuth citrate

Tubulin Modulators

Antimitotic Agents

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 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

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

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

Amit Oza

Nicole Chau

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.

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.

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

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

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.

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.

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.

Survival: 30-day(all cause and disease-specific), 60-day(all cause and disease-specific), and 90-day mortality (all cause and disease-specific).

Summary statistics will be used to summarize the patients. Survival estimates will be computed using Kaplan-Meier method. Variable association will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses. Non-parametric tests may be substituted if necessary. Results will be illustrated using figures and plots using 95 percent confidence intervals.

All patients will be evaluable for toxicity from the time they sign consent.

University Health Network, Toronto

Cardiotonic Agents

Octreotide

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.

Amy Case, MD

To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.

Palliative Management of Inoperable Malignant Bowel Obstruction

Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center

The primary efficacy endpoint is the proportion of eligible patients whose malignant bowel obstruction clears (de-obstruction) within 7 days of starting the protocol therapy. Patients meeting de-obstruction criteria within 7 days will be deemed treatment successes.

De-obstruction is defined as:

* Effective introduction of oral intake (yes/no)
* Distinguished from small volumes of oral fluid that may be allowed with unresolved MBO
* Tolerating oral liquid diet (day 1 of de-obstruction) that is able to be progressively more solid (oral or enteral)
* Cessation of vomiting or ability for NGT or venting G tube to remain clamped without vomiting

Rate of de-obstruction is defined as:

- From the date of study enrollment to the first observation of de-obstruction.

Roswell Park Cancer Institute

IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.

Dexamethasone: Given IV

Metoclopramide: Given IV

Octreotide: Given IV

Treatment (Octreotide, Dexamethasone, Metoclopramide)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

KARNOFSKY PERFORMANCE STATUS SCALE

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses.

The score ranges from 0 to 100.

Performance Status

Kris Attwood

2 Patients did not complete treatment and were not evaluated for de-obstruction (due to AEs).

Proportion of Patients With Obstruction Clearance

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Ovarian Cancer Peritoneal Canc... Fallopian Tube ... Bowel Obstructi...	Cisplatin Paclitaxel	18 Years -	University Health Network, Toronto
Palliative Management of Inoperable Malignant Bowel Obstruction	NCT04027348	Malignant Bowel...	Dexamethasone Metoclopramide Octreotide	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for malignant bowel obstruction