Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: June 25, 2007
Last updated: December 31, 2012
Last verified: December 2012
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: Continual assessment during each 21 day cycle ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
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.
Starting dose level 2.5 mg/kg given intravenously on day 1.
- Anti-VEGF monoclonal antibody
Starting dose level 25 mg/m^2 given intraperitoneally on day 2.
Other Name: Eloxatin
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (0-2).
- 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.
- Patients must be able to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document.
- Patients must have evidence of peritoneal carcinomatosis that is evaluable by computer tomography (CT) or magnetic resonance imaging (MRI).
- 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.
- 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.
- 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.
- 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.
- History of allergic reactions to the study drugs or their analogs.
- Failure to recover from any prior surgery within 4 weeks of study entry.
- 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.
- 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.
- Serious non-healing wound, ulcer, bone fracture (including abdominal fistula, gastrointestinal perforation or intra-abdominal abscess), or history of bleeding diathesis.
- History of radiotherapy to the abdominal and pelvic regions or history of multiple abdominal surgeries that contraindicates this protocol therapy.
- 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).
- Grade 2 or greater neuropathy, and history of brain or leptomeningeal metastases that significantly increase risks of intracranial bleeding.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491855
|U.T.M.D. Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Apostolia Tsimberidou, MD, PhD
||M.D. Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 25, 2007
||December 31, 2012
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Advanced Peritoneal Carcinomatosis
vascular endothelial growth factor
Anti-VEGF monoclonal antibody
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Modulating Agents