Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis

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. Identifier: NCT00491855
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. The safety of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Peritoneal Cancer Drug: Bevacizumab Drug: Oxaliplatin Drug: Paclitaxel Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis
Study Start Date : June 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Bevacizumab + Oxaliplatin + Paclitaxel
One cycle of treatment is 21 days. Bevacizumab starting dose level 2.5 mg/kg given intravenously on day 1. Oxaliplatin starting dose level 25 mg/m^2 given intraperitoneally on day 2. Paclitaxel starting dose level 110 mg/m^2 given continuous infusion on day 1 and 30 mg/m^2 given intraperitoneally on day 8.
Drug: Bevacizumab
Starting dose level 2.5 mg/kg given intravenously on day 1.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Drug: Oxaliplatin
Starting dose level 25 mg/m^2 given intraperitoneally on day 2.
Other Name: Eloxatin

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.
Other Name: Taxol

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Continual assessment during each 21 day cycle ]

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.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Eastern Cooperative Oncology Group (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 alanine aminotransferase (ALT) <2.5 * 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 Institutional Review Board (IRB)-approved written informed consent document.
  5. Patients must have evidence of peritoneal carcinomatosis that is evaluable by computer tomography (CT) or magnetic resonance imaging (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 prothrombin time (PT)/ partial thromboplastin time (PTT) within 1.2 * the institutional upper limit of normal or < 3 * 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.

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 identifier (NCT number): NCT00491855

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00491855     History of Changes
Other Study ID Numbers: 2006-1068
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Peritoneal Carcinomatosis
Peritoneal Cancer
vascular endothelial growth factor
Anti-VEGF monoclonal antibody

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors