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Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis


Phase 1
N/A
N/A
Not Enrolling
Both
Carcinoma, Peritoneal Neoplasm

Thank you

Trial Information

Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis


Peritoneal carcinomatosis is considered a terminal stage of tumor progression.
Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may
significantly alter the natural history of this disease. This study will define the maximum
tolerated dose of paclitaxel and 5-fluorouracil (5-FU) given as an early post-operative
intraperitoneal (IP) dwell therapy after cytoreductive surgery and continuous hyperthermic
peritoneal perfusion with cisplatin (CHPP).

Inclusion Criteria


The patients must have an ECOG performance status of 0 or 1 and have no concomitant
medical problems that would place them at increased risk for a major surgical procedure
(EG, cardiac or pulmonary disabilities).

Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age
greater than 65, history of hypertension, first degree relative with atherosclerotic
coronary artery disease) will undergo cardiac evaluation and performed which will include
an attempt to remove all disease greater than 0.5 cm in diameter.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

970072

NCT ID:

NCT00001569

Start Date:

January 1997

Completion Date:

December 2002

Related Keywords:

  • Carcinoma
  • Peritoneal Neoplasm
  • Gastrointestinal
  • Adenocarcinoma
  • Taxol
  • Neoplasms
  • Carcinoma
  • Fever
  • Peritoneal Neoplasms

Name

Location
National Cancer Institute (NCI) Bethesda, Maryland  20892