Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00626561
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    10 mg/kg IV twice weekly on days 1 and 15.
  • Paclitaxel — DRUG
    60 mg/m\^2 IV weekly on days 1, 8, 15, and 22.

Study Details

Objectives: Primary: To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free survival. Secondary: 1. To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by overall survival. 2. To determine the response rates in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel. 3. To characterize the quality of life (QoL) in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel. 4. To determine the nature and degree of toxicity in patients with advanced or recurrent small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.

Key Dates

First listed
Feb 29, 2008
Start date
Feb 29, 2008
Status verified
Jun 2014
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: Bevacizumab + Paclitaxel
    Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Baseline to 6 Months, or until disease progression. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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