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Trial record 1 of 1 for:    NCT01061515
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Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01061515
Recruitment Status : Active, not recruiting
First Posted : February 3, 2010
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma Drug: Intraperitoneal Oxaliplatin Drug: Bevacizumab Drug: Capecitabine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2011
Estimated Primary Completion Date : September 27, 2020
Estimated Study Completion Date : September 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Level 1

Intraperitoneal oxaliplatin 25 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Drug: Intraperitoneal Oxaliplatin
Other Name: Eloxatin

Drug: Bevacizumab
Other Name: Avastin

Drug: Capecitabine
Other Name: Xeloda

Experimental: Dose Level 2

Intraperitoneal oxaliplatin 50 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Drug: Intraperitoneal Oxaliplatin
Other Name: Eloxatin

Drug: Bevacizumab
Other Name: Avastin

Drug: Capecitabine
Other Name: Xeloda

Experimental: Dose Level 3

Intraperitoneal oxaliplatin 65 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Drug: Intraperitoneal Oxaliplatin
Other Name: Eloxatin

Drug: Bevacizumab
Other Name: Avastin

Drug: Capecitabine
Other Name: Xeloda

Experimental: Dose Level 4

Intraperitoneal oxaliplatin 85 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Drug: Bevacizumab
Other Name: Avastin

Experimental: Dose Level 5

Intraperitoneal oxaliplatin 100 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Drug: Intraperitoneal Oxaliplatin
Other Name: Eloxatin

Drug: Bevacizumab
Other Name: Avastin

Drug: Capecitabine
Other Name: Xeloda




Primary Outcome Measures :
  1. 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 8 years) ]
  2. Assess the safety and tolerability of IP oxaliplatin and intravenous (i.v.) bevacizumab and oral capecitabine after surgical debulking and functional intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology [ Time Frame: 30 days after completion of treatment ]
  3. To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen. [ Time Frame: 1 year post treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061515


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Benjamin Tan, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01061515    
Other Study ID Numbers: 10-0136 / 201107017
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action