drugset / 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

NCT01083537 ↗

Phase 1/2 Terminated 1 enrolled University Health Network, Toronto
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-02
Primary completion
2012-06
Completion
2012-06

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous