Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00491855
Phase
PHASE1
Status
Completed

Conditions

  • Peritoneal Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Starting dose level 2.5 mg/kg given intravenously on day 1.
  • Oxaliplatin — DRUG
    Starting dose level 25 mg/m\^2 given intraperitoneally on day 2.
  • Paclitaxel — DRUG
    Starting dose level 110 mg/m\^2 given continuous infusion on day 1 and 30 mg/m\^2 given intraperitoneally on day 8.

Study Details

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.

Key Dates

First listed
Jun 26, 2007
Start date
Jun 30, 2007
Status verified
Dec 2012
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Continual assessment during each 21 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

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