Clinical trial NCT01083537: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Bowel Obstruction
Keywords: malignant bowel obstruction
ovarian cancer
Peritoneal cancer
Fallopian Tube cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Safety Profile
timeFrame: Day 1 of treatment until resolution of symptoms
measure: Quality of Life Scores at Baseline, Day 30 and Day 90
timeFrame: Day 1 of treatment until resolution of symptoms
measure: Time to Resolution of Bowel Obstruction
timeFrame: Day 1 of treatment until resolution of symptoms
Secondary outcomes:
measure: Survival
timeFrame: 30 days, 60 days, and 90 days from treatment start date
measure: Evaluation of Toxicity
timeFrame: Time of consent until resolution of symptoms
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Amit Oza
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Nicole Chau
role: PRINCIPAL_INVESTIGATOR
References: