5137S-11: City of Hope Abraxane peritoneal

CRC 11006: Phase I Trial of Intraperitoneal nab-Paclitaxel (Abraxane®) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

Type of Study
Cancer (Oncology) - Peritoneal
Location
Swedish Cancer Institute
Short Description
Purpose: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity.
Status
Open to Enrollment
Principal Investigator
Min Park, M.D.
Eligibility Notes
  • Patients must have histological confirmed advanced cancer primarily confined to the peritoneal cavity which have progressed on previous chemotherapeutic regimens, or for which no "standard" chemotherapeutic regimens exist
  • Prior taxane exposure is allowed; prior IP chemotherapy is allowed, if it was not complicated by peritoneal adhesions; patients with ovarian cancer having residual disease at second-look laparotomy or following secondary debulking are also eligible; patients must be 4-6 weeks after surgery and they must have recovered from the surgery prior to initiating IP chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
  • No patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administer more than 4 weeks earlier; there is no limit on the number of prior lines of chemotherapy
  • Patients with ongoing abdominal infections or bowel obstruction
  • Patients with known peritoneal adhesions that preclude the placement of an intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal catheter
  • Pre-existing grade >= 2 sensory neuropathy
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org