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
NCT ID: NCT00352755
Last Updated: 2016-12-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2006-05-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peritonectomy + IP5FU + FOLFOX
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
Surgical debulking with peritonectomy
Intraperitoneal 5FU
FOLFOX
Interventions
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Surgical debulking with peritonectomy
Intraperitoneal 5FU
FOLFOX
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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James Fleshman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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06-0312
Identifier Type: -
Identifier Source: org_study_id