Clinical Trials /

Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

NCT01061515

Description:

This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC) from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced and have undergone a peritoneal scan demonstrating patency of at least one of the intraperitoneal ports that were placed at the time of debulking.

Related Conditions:
  • Appendix Adenocarcinoma
  • Colorectal Adenocarcinoma
  • Peritoneal Carcinomatosis
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer
  • Official Title: A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 10-0136 / 201107017
  • NCT ID: NCT01061515

Conditions

  • Carcinoma

Interventions

DrugSynonymsArms
Intraperitoneal OxaliplatinEloxatinDose Level 1
BevacizumabAvastinDose Level 1
CapecitabineXelodaDose Level 1

Purpose

This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC) from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced and have undergone a peritoneal scan demonstrating patency of at least one of the intraperitoneal ports that were placed at the time of debulking.

Detailed Description

      -  To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous
           bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan
           documenting function of intraperitoneal ports in patients with peritoneal
           carcinomatosis of appendiceal or colorectal etiology.

        -  To assess the safety and tolerability of repeated delayed intraperitoneal chemotherapy
           with oxaliplatin and systemic intravenous bevacizumab and oral capecitabine after
           adequate surgical debulking and peritoneal scan documenting function of intraperitoneal
           ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.

        -  To describe the progression rate, progression-free survival and overall survival in
           patients treated with this regimen.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Level 1ExperimentalIntraperitoneal oxaliplatin 25 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine 850 mg/m2 PO BID on days 1-7 of each cycle. Each cycle is 14 days long.
  • Intraperitoneal Oxaliplatin
  • Bevacizumab
  • Capecitabine
Dose Level 2ExperimentalIntraperitoneal oxaliplatin 50 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine 850 mg/m2 PO BID on days 1-7 of each cycle. Each cycle is 14 days long.
  • Intraperitoneal Oxaliplatin
  • Bevacizumab
  • Capecitabine
Dose Level 3ExperimentalIntraperitoneal oxaliplatin 65 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine 850 mg/m2 PO BID on days 1-7 of each cycle. Each cycle is 14 days long.
  • Intraperitoneal Oxaliplatin
  • Bevacizumab
  • Capecitabine
Dose Level 4ExperimentalIntraperitoneal oxaliplatin 85 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine 850 mg/m2 PO BID on days 1-7 of each cycle. Each cycle is 14 days long.
  • Bevacizumab
Dose Level 5ExperimentalIntraperitoneal oxaliplatin 100 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine 850 mg/m2 PO BID on days 1-7 of each cycle. Each cycle is 14 days long.
  • Intraperitoneal Oxaliplatin
  • Bevacizumab
  • Capecitabine

Eligibility Criteria

        Inclusion Criteria:

          -  Histological Diagnosis: Patients must have a histologically documented peritoneal
             carcinomatosis from either colorectal or appendiceal adenocarcinoma.

          -  Prior Surgical Debulking: Patients must have undergone debulking surgery with
             peritonectomy and have been allowed at least 4 weeks to recover prior to receiving
             chemotherapy.

          -  Port Placement: Intraperitoneal ports may be placed during or at any time separate
             from surgical debulking. Provided the patient has been allowed at least 4 weeks to
             recover from surgical debulking, no additional recovery time is required for port
             placement.

          -  Active port: Patients must undergo a peritoneal scan documenting at least one working
             intraperitoneal port prior to receiving chemotherapy.

          -  Patients may have received prior chemotherapy.

          -  Age: Patients must be ≥18 years of age. Because no dosing or toxicity data are
             currently available on the use of oxaliplatin in patients <18 years of age.

          -  Performance Status: (Eastern cooperativeOncology Group) ECOG 0-2.

          -  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
             arrhythmias.

          -  Informed Consent: All patients must be consented prior to chemotherapy. The patient
             should not have any serious medical of psychiatric illness that would prevent either
             the giving of informed consent or the receipt of treatment.

          -  Hematological Status:

               -  absolute neutrophil count ≥1,500/mm³

               -  platelet count ≥100,000/mm³

               -  hemoglobin ≥8 g/dl.

          -  Hepatic function:

               -  Total bilirubin must be <2X the institutional upper limit of normal (ULN)

               -  Transaminases (SGOT and/or SGPT) must be ≤3X the institutional upper limit of
                  normal (ULN)

               -  Alkaline phosphatase must be ≤4X the institutional upper limit of normal (ULN)

          -  Renal Function: Patients must have adequate renal function prior to chemotherapy
             defined as serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml.min/1.73 m²
             for patients with creatinine levels above 2.0 mg/dl.

        Exclusion Criteria:

          -  Pregnant or breast feeding: For all sexually active patients, the use of adequate
             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.

          -  Prior history of hypersensitivity reactions to oxaliplatin, bevacizumab, 5-FU or
             capecitabine.

          -  Gastrointestinal ailments that may alter the absorption of oral medications (i.e.
             bowel obstruction, short-gut syndrome).

          -  Patients receiving antiretroviral therapy Highly Active Anti Retroviral Treatment
             (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.

          -  Patients with Grade 2 or higher peripheral neuropathy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after surgical debulking and peritoneal scan documenting functional of intraperitoneal ports in patients with peritoneal carcinomatosis
Time Frame:Completion of enrollment (approximately 6 years)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Washington University School of Medicine

Last Updated

April 5, 2017