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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Peritoneal Neoplasms

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of the planned treatment regimen

Outcome Time Frame:

30 days after end of treatment

Safety Issue:

Yes

Principal Investigator

James Fleshman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

06-0312

NCT ID:

NCT00352755

Start Date:

May 2006

Completion Date:

April 2009

Related Keywords:

  • Peritoneal Neoplasms
  • Neoplasms
  • Peritoneal Neoplasms
  • Pseudomyxoma Peritonei
  • Carcinoma

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110