Project: Research project

Project Details


No satisfactory treatment exists for disseminated intraperitoneal
malignancies. This manifestation of advanced cancer has a poor survival
and a dismal quality of life. Recent in vitro data has suggested that
heat, in combination with various chemotherapeutic agents, including
mitomycin C (MMC), has synergistic cytotoxicity against a variety of
human cancer cell lines. Our preliminary clinical research has
demonstrated that cytoreductive surgery, followed by intraperitoneal
hyperthermic chemotherapy (IPHC) with MMC, is well-tolerated and perhaps
effective (prolonged survival, eradication of ascites) in the treatment
of peritoneal carcinomatosis. Our proposed Phase I-Il clinical studies
will evaluate the safety, efficacy, and impact on quality of life of this
novel treatment: cytoreductive surgery followed by IPHC with MMC. During
the Phase l study, patients with histologically-proven malignancies of
gastrointestinal or ovarian origin confined to the peritoneal cavity are
eligible. Only patients with peritoneal carcinomatosis of
gastrointestinal origin are eligible for the Phase Il study. During the
Phase I-Il studies, patients will undergo cytoreductive surgery followed
by a two-hour, heated peritoneal perfusion of MMC. The maximally
tolerated perfusion inflow temperature (MMC dose is fixed at 40 mg)
identified during the Phase l study will be used in ali Phase Il Study
patients. During both study phases the peritoneal, plasma, and urinary
pharmacokinetics of MMC will be determined. Outcome measures to be
compared with pre-operative baseline studies include the presence of
cytology positive cells in peritoneal washings, concentrations of serum
tumor markers, presence of ascites, quality of life, and survival. Our
proposed studies will assist in the development of a novel therapy which
may have a positive impact on the long-term survival and quality of life
in patients with peritoneal carcinomatosis of gastrointestinal origin.
Effective start/end date8/9/955/31/00


  • National Cancer Institute
  • National Cancer Institute
  • National Cancer Institute
  • National Cancer Institute
  • National Cancer Institute
  • National Cancer Institute


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