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Continuous Hyperthermic Peritoneal Perfusion With Cisplatin Plus Intraperitoneal Paclitaxel and Fluorouracil Following Surgery in Treating Patients With Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020059
  Purpose

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs following surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well continuous hyperthermic peritoneal perfusion of cisplatin plus intraperitoneal infusions of paclitaxel and fluorouracil work in treating patients who have undergone surgery for peritoneal cancer.


Condition Intervention Phase
Carcinoma of the Appendix
Colorectal Cancer
Peritoneal Cavity Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: hyperthermia treatment
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival at 6 or 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 179
Study Start Date: February 2000
Detailed Description:

OBJECTIVES:

  • Determine response and survival of patients with peritoneal carcinomatosis treated with continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with fluorouracil and paclitaxel.
  • Determine the pharmacokinetics of paclitaxel and fluorouracil administered into the peritoneal cavity in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients are stratified according to histology (primary peritoneal mesothelioma vs low-grade mucinous adenocarcinoma [including low-grade mucinous neoplasms of borderline malignant potential] [closed to accrual as of 11/14/03] vs adenocarcinoma of gastrointestinal tract origin [other than low-grade mucinous, excluding pancreatic cancer]).

Patients undergo cytoreductive surgery plus continuous hyperthermic peritoneal perfusion with cisplatin over 90 minutes on day 1 followed by intraperitoneal dwell chemotherapy with paclitaxel and fluorouracil over 60 minutes during the early postoperative period (days 7-12).

Quality of life is assessed at study initiation, at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

Patients are followed at 4-6 weeks, every 3 months for 1 year, and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 179 patients (72 with peritoneal mesothelioma, 48 with low-grade mucinous adenocarcinoma [closed to accrual as of 11/14/03], and 59 with adenocarcinoma of gastrointestinal tract origin) will be accrued for this study within approximately 5-6 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed peritoneal carcinomatosis with the following histologies:

    • Primary peritoneal mesothelioma
    • Low-grade mucinous adenocarcinoma (including low-grade mucinous neoplasms of borderline malignant potential) (closed to accrual as of 11/14/03)
    • Adenocarcinoma of gastrointestinal tract origin (other than low-grade mucinous, excluding pancreatic cancer)
  • Confined to peritoneal cavity
  • Able to be debulked to residual size of less than 1 cm in diameter per tumor deposit
  • Must not have failed prior intraperitoneal platinum therapy

    • Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 6 months after therapy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 8 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST and ALT no greater than 5 times ULN
  • Liver enzymes no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 70 mL/min

Cardiovascular:

  • No significant irreversible cardiac ischemia
  • Ejection fraction at least 40%

Pulmonary:

  • FEV_1 at least 1.2 liters
  • Maximum voluntary ventilation at least 50% expected

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Weight at least 30 kg
  • No concurrent medical problems that would preclude surgery
  • No neurological toxicity of grade 3 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior immunotherapy and recovered

Chemotherapy:

  • See Disease Characteristics
  • At least 30 days since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 30 days since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020059

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Marybeth S. Hughes, MD NCI - Surgery Branch
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067690, NCI-00-C-0069
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00020059     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
adenocarcinoma of the colon
signet ring adenocarcinoma of the colon
carcinoma of the appendix
pseudomyxoma peritonei
peritoneal cavity cancer

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Colonic Diseases
Rectal Diseases
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Digestive System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Antimitotic Agents
Intestinal Diseases
Abdominal Neoplasms
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Fluorouracil
Tubulin Modulators
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009