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

NCT00352755 | Terminated Phase 2 Results

• 1 other identifier: 06-0312
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events

  30 days after end of treatment

Secondary Outcomes (4)

• Progression Rate

  Median follow-up was 32 months

• Number of Participants Who Experience Surgical Complications Associated With This Regimen

  Median follow-up was 32 months

• Progression-free Survival

  Median follow-up was 32 months

• Overall Survival

  Median follow-up was 32 months

Study Arms (1)

Peritonectomy + IP5FU + FOLFOX

EXPERIMENTAL

* 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.

Procedure: Surgical debulking with peritonectomy; Drug: Intraperitoneal 5FU; Drug: FOLFOX

Interventions

Surgical debulking with peritonectomy PROCEDURE

Peritonectomy + IP5FU + FOLFOX

Intraperitoneal 5FU DRUG

Also known as: Fluorouracil, Efudex

Peritonectomy + IP5FU + FOLFOX

FOLFOX DRUG

Also known as: Oxaliplatin, Fluorouracil, Efudex, Leucovorin, USAN

Peritonectomy + IP5FU + FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Fluorouracil; Folfox protocol; Oxaliplatin; Leucovorin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Dr. James Fleshman
• Organization: Washington University School of Medicine

James.Fleshman@BSWHealth.org

314-747-4610

Study Officials

• James Fleshman, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2006
• First Posted: July 17, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 13, 2016
• Results First Posted: December 13, 2016

Record last verified: 2016-10

Locations

US (1)