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Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, March 2009
First Received: June 25, 2007   Last Updated: March 16, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00491855
  Purpose

Primary Objectives:

  1. To establish acceptable dosages of paclitaxel, oxaliplatin and bevacizumab in a regimen of intravenous bevacizumab followed by continuous intravenous infusion of paclitaxel on day 1, intraperitoneal oxaliplatin on day 2, and intraperitoneal paclitaxel on day 8 once every 3 weeks in patients with advanced peritoneal carcinomatosis.
  2. To assess toxicity profile.
  3. To assess clinical responses.

Condition Intervention Phase
Peritoneal Cancer
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Paclitaxel
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel Oxaliplatin Bevacizumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: June 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Bevacizumab + Oxaliplatin + Paclitaxel
Drug: Bevacizumab
Starting dose level 2.5 mg/kg given intravenously on day 1.
Drug: Oxaliplatin
Starting dose level 25 mg/m^2 given intraperitoneally on day 2.
Drug: Paclitaxel
Starting dose level 110 mg/m^2 given continuous infusion on day 1 and 30 mg/m^2 given intraperitoneally on day 8.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have advanced peritoneal carcinomatosis: they have either a disease where there is no established standard of care therapy or have failed one or more prior therapy. These include, but not limited to, recurrent epithelial ovarian cancer, advanced endometrial cancer, advanced gastric cancer, advanced colorectal cancer, and advanced primary peritoneal mesothelioma without significant chest involvement. Previous intraperitoneal therapy with different agents is allowed as long as their diseases have progressed.
  2. Patients must have ECOG performance status < or = 2 (0-2).
  3. Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > or = 1,500/mcL Platelets > or = 100,000/mcL Total bilirubin < or = 2.0 and ALT <2.5 X the institutional upper limit of normal; Creatinine < or = 2.0 mg/dL or creatinine clearance > or = 40mL/min/1.73m2.
  4. Patients must be able to understand and the willingness to sign an IRB-approved written informed consent document.
  5. Patients must have evidence of peritoneal carcinomatosis that is evaluable by CT or MRI.
  6. In the clinical judgment of the investigator, patients must have adequate potential intraperitoneal fluid distribution with no gross fluid loculations and adhesions that would significantly affect intraperitoneal drug distribution. This determination may be made based on documented clinical, imaging or laboratory assessment.
  7. Patients must have PT/PTT within 1.2 x the institutional upper limit of normal or < 3 x the institutional upper limit of normal on anticoagulants.
  8. Patients must have resting blood pressure no greater than 140 mmHg(systolic) or 90 mmHg (diastolic) for eligibility. Initiation or adjustment of blood pressure medication is permitted prior to study entry.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.
  2. History of allergic reactions to the study drugs or their analogs.
  3. Failure to recover from any prior surgery within 4 weeks of study entry.
  4. Pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and for at least 3 months after the last treatment.
  5. Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 wks for nitrosoureas or mitomycin C), or within 5 half-lives for target agents with half lives and pharmacodynamic effects lasting less than 5 days (that include but are not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to recover from the toxic effect of any therapy prior to study entry.
  6. Serious non-healing wound, ulcer, bone fracture (including abdominal fistula, gastrointestinal perforation or intra-abdominal abscess), or history of bleeding diathesis.
  7. History of radiotherapy to the abdominal and pelvic regions or history of multiple abdominal surgeries that contraindicates this protocol therapy.
  8. Urine dipstick for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible).
  9. Grade 2 or greater neuropathy, and history of brain or leptomeningeal metastases that significantly increase risks of intracranial bleeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491855

Contacts
Contact: Apostolia Tsimberidou, MD, PhD 713-792-4259

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Apostolia Tsimberidou, MD, PhD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Apostolia Tsimberidou, MD, PhD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T. M.D. Anderson Cancer Center ( Apostolia M. Tsimberidou MD, PhD/Assistant Professor )
Study ID Numbers: 2006-1068
Study First Received: June 25, 2007
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00491855     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Peritoneal Carcinomatosis
Peritoneal Cancer
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF
Oxaliplatin
Eloxatin
Paclitaxel
Taxol

Study placed in the following topic categories:
Digestive System Neoplasms
Immunologic Factors
Antimitotic Agents
Bevacizumab
Abdominal Neoplasms
Angiogenesis Inhibitors
Carcinoma
Antibodies, Monoclonal
Oxaliplatin
Antibodies
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Diseases
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Antibodies, Monoclonal
Oxaliplatin
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms by Histologic Type
Digestive System Neoplasms
Growth Substances
Mitosis Modulators
Antimitotic Agents
Abdominal Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009