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

Phase 1
18 Years
Not Enrolling

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Trial Information

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

Because the combination of gemcitabine and docetaxel has shown impressive activity in soft
tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab)
would enhance the anticancer activity, as shown in other tumor types.

Inclusion Criteria

Inclusion criteria:

- All patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma
are eligible if there is measurable disease Prior surgery or radiotherapy for the
primary tumor is allowed but needs to have been completed at least 2 weeks from
entry, and patient should have completely recovered from the procedures.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence
of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is overall response rate (complete and partial responses).

Outcome Time Frame:

As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment

Safety Issue:


Principal Investigator

Claire Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:

INST 0509C



Start Date:

November 2005

Completion Date:

November 2010

Related Keywords:

  • Sarcoma
  • Soft Tissue Sarcoma
  • Phase I
  • Gemcitabine
  • Docetaxel
  • Bevacizumab
  • VEGF
  • Sarcoma



New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
University of New Mexico Albuquerque, New Mexico  87131
Hematology Oncology Associates Albuquerque, New Mexico  87106
St. Vincent Regional Medical Center Santa Fe, New Mexico  87505