Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00887809
Phase
PHASE2
Status
Completed

Conditions

  • Angiosarcoma
  • Histiocytoma
  • Leiomyosarcoma
  • Malignant Fibrous
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • gemcitabine — DRUG
  • docetaxel — DRUG
  • bevacizumab — DRUG

Study Details

The purpose of this study is to test whether an experimental drug called bevacizumab given together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can help sarcoma patients. This trial will examine what effects, good and/or bad the combination of gemcitabine, docetaxel and bevacizumab has on sarcoma.

Key Dates

First listed
Apr 24, 2009
Start date
Apr 30, 2009
Status verified
Dec 2015
Primary completion
Oct 31, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: gemcitabine and docetaxel with bevacizumab
    Patients will receive bevacizumab at 15 mg/kg on day 1 of each 21-day cycle intravenously over 30 minutes followed by a one hour (+30/-15 min) break. For cycles 1 through 6, gemcitabine will be administered at 900 mg/m2 over 90 minutes on day 1 and 8 of a 21-day cycle. Docetaxel will be administered at 75 mg/m2, over 60 minutes, on day 8. This will be followed by either 5 days of filgrastim or a single injection of pegfilgrastim. For cycles 7 and beyond, gemcitabine will be given at 800 mg/m2 over 30 minutes on day 1 and 8; docetaxel will be given at 35 mg/m2 over 30 minutes, also on days 1 and 8.

Primary Outcome Measure

Overall Objective Response [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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