A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin/5FU/Leucovorin in Patients With Pseudomyxoma Peritonei or Peritoneal Carcinomatosis
Condition: Peritoneal Neoplasms
MeSH terms: Carcinoma; Peritoneal Neoplasms; Pseudomyxoma Peritonei
Intervention: Surgical debulking with peritonectomy; Intraperitoneal 5FU; FOLFOX
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study prospectively evaluates a multidisciplinary approach to patients with
      intraperitoneal carcinomatosis at Washington University. Patients with peritoneal
      carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy
      and placement of adhesive barrier film followed by repeated delayed intraperitoneal
      chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule. A
      retrospective review of patients treated in a similar manner at our institution showed good
      tolerance and efficacy. This formal Phase II study is planned to determine the safety,
      toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei
      treated with this regimen.
    

Eligibility criteria:

        Eligibility Criteria:

          -  Histological Diagnosis: Patients must have a histologically documented pseudomyxoma
             peritonei or peritoneal carcinomatosis from colorectal/appendiceal and small
             intestinal adenocarcinoma.

          -  Patients may have prior chemotherapy.

          -  Age: Patients must be greater than or equal to 18 years old. Because no dosing or
             toxicity data are currently available on the use of oxaliplatin in patients <18 years
             of age, children are excluded from this study, but will be eligible for other
             pediatric Phase I single-agent trials, when available.

          -  Performance Status: ECOG 0-2.

          -  Life Expectancy: greater than 8 weeks.

          -  Recovery from Intercurrent Illness: Patients must have recovered from uncontrolled
             intercurrent illness including, but not limited to, ongoing or active infection,
             symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.

          -  Hematological Status: Patients must have adequate bone marrow function defined as an
             absolute neutrophil count greater than or equal to 1,500/mm3, platelet count greater
             than or equal to 100,000/mm3 and hemoglobin greater than or equal to 8 g/dl.

          -  Hepatic Function: Total bilirubin must be less than or equal to institutional upper
             limit of normal (ULN). Transaminases (SGOT and/or SGPT) may be up to 2.5 X ULN if
             alkaline phosphatase is less than or equal to ULN, or alkaline phosphatase may be up
             to 4 x ULN if transaminases are less than or equal to ULN. However, patients who have
             both transaminase elevation greater than 1.5 x ULN and alkaline phosphatase greater
             than 2.5 x ULN are not eligible for the study.

          -  Renal Function: Patients must have adequate renal function defined as serum creatinine
             less than or equal to 2.0 mg/dl or creatinine clearance greater than or equal to 60
             ml/min/1.73 m2 for patients with creatinine levels above 2.0 mg/dl.

          -  Sexually Active Patients: For all sexually active patients, the use of adequate
             barrier contraception (hormonal or barrier method of birth control) will be required
             during therapy, prior to study entry and for the duration of study participation.
             Non-pregnant status will be determined in all women of childbearing potential.
             Pregnant and nursing women patients are not eligible.

          -  HIV-Positive Patients: Patients receiving anti-retroviral therapy (HAART) for HIV
             infection are excluded from the study because of possible pharmacokinetic
             interactions. Appropriate studies will be undertaken in patients receiving HAART
             therapy, when indicated.

          -  Informed Consent: After being informed of the treatment involved, patients must give
             written consent. The patient should not have any serious medical or psychiatric
             illness that would prevent either the giving of informed consent or the receipt of
             treatment.

          -  Inclusion of Women and Minorities: Entry to this study is open to both men and women
             and to all racial and ethnic subgroups.