Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT00276055
Phase
PHASE1
Status
Completed

Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

  • Gemcitabine, Docetaxel and Bevacizumab — DRUG
    During the treatment phase, pts. will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks. This 4-week period is called a cycle of treatment. The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period. Pts. will then receive bevacizumab IV over a 30-minute period. Pts. will receive this treatment once every 2 weeks. Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects. As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment

Study Details

1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab. 1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma

Key Dates

First listed
Jan 12, 2006
Start date
Nov 30, 2005
Status verified
Jun 2015
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    1000mg/m2 gemcitabine
  • Experimental: Cohort 2
    1250 mg/m2 gemcitabine
  • Experimental: Cohort 3
    1500 mg/m2 gemcitabine

Primary Outcome Measure

Overall response rate (complete and partial responses). [ Time Frame: 4 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Hematology Oncology AssociatesAlbuquerqueNew Mexico87102-3661-
University of New MexicoAlbuquerqueNew Mexico87131-
New Mexico Cancer Care AssociatesSanta FeNew Mexico87508-
St. Vincent Regional Medical CenterSanta FeNew Mexico87505-

Find similar trials in Albuquerque, NM

By research site
Hematology Oncology Associates· Albuquerque, NMUniversity of New Mexico· Albuquerque, NMNew Mexico Cancer Care Associates· Santa Fe, NMSt. Vincent Regional Medical Center· Santa Fe, NM

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