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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

Phase 1/Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Bowel Obstruction

Thank you

Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Safety Profile

Outcome Description:

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.

Outcome Time Frame:

Day 1 of treatment until resolution of symptoms

Safety Issue:


Principal Investigator

Amit Oza

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

February 2010

Completion Date:

June 2012

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Bowel Obstruction
  • malignant bowel obstruction
  • ovarian cancer
  • Peritoneal cancer
  • Fallopian Tube cancer
  • Intestinal Obstruction
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms