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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01061515
First received: February 1, 2010
Last updated: April 4, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Carcinoma
Drug: Intraperitoneal Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 3 years) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen. [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: May 2011
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 850 mg/m2 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 850 mg/m2 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 850 mg/m2 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 850 mg/m2 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 850 mg/m2 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 and Port Placements: Patients must have undergone debulking surgery with peritonectomy and placement of intraperitoneal ports and have been allowed at least 4 weeks to recover prior to receiving chemotherapy.
  • 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.
  • Inclusion of Women and Minorities: Entry to this study is open to both men and women and to all racial and ethnic subgroups.
  • 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, and 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061515

Contacts
Contact: Benjamin Tan, M.D. 314-362-9115 btan@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Benjamin Tan, M.D.    314-362-9115    btan@dom.wustl.edu   
Sub-Investigator: Matthew Mutch, M.D.         
Sub-Investigator: Steven Sorscher, M.D.         
Sub-Investigator: A. Craig Lockhart, M.D.         
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Bashar Safar, MBBS, MRCS         
Sub-Investigator: Caron Rigden, M.D.         
Sub-Investigator: Elisa H Birnbaum, M.D.         
Sub-Investigator: Tanya Wildes, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Benjamin Tan, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01061515     History of Changes
Other Study ID Numbers: 10-0136 / 201107017
Study First Received: February 1, 2010
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Bevacizumab
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014