Phase I/II Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma - Full Text View

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00276055

Purpose

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

Condition	Intervention	Phase
Sarcoma	Drug: Gemcitabine, Docetaxel and Bevacizumab	Phase I Phase II

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

The primary endpoint is overall response rate (complete and partial responses). [ Time Frame: As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2005
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276055

Contacts

Contact: Leanne Gideon

505-272-5688

lgideon@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Leanne Gideon 505-272-5688 lgideon@salud.unm.edu
Principal Investigator: Claire Verschraegen, MD
Hematology Oncology Associates	Recruiting
Albuquerque, New Mexico, United States, 87102-3661
Contact: Debbie Winklejohn 505-938-5858 debbiew@hoanm.com
Principal Investigator: Malcolm Purdy, MD
New Mexcio Veterans Administration Health Care System	Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Elizabeth McGuire, MD Elizabeth.McGuire@med.va.gov
Principal Investigator: Elizabeth McGuire, MD
New Mexico Cancer Care Associates	Recruiting
Santa Fe, New Mexico, United States, 87508
Contact: Carmen Angel 505-955-7910 c.angel@nmcancercare.com
Contact: Frances Jaramillo frances.jaramillo@nmcancercare.com
Principal Investigator: Timothy Lopez, MD
St. Vincent Regional Medical Center	Recruiting
Santa Fe, New Mexico, United States, 87505
Contact: Beth Carlozzi Beth.Corlozzi@stvin.org
Principal Investigator: Maury Blitman, MD

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Claire Verschraegen, MD

University of New Mexico

More Information

Responsible Party:	Universtiy of New Mexico - CRTC ( Claire Verschraegen, MD; Principal Investigator )
Study ID Numbers:	INST 0509C
Study First Received:	January 11, 2006
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00276055
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Soft Tissue Sarcoma
Phase II
Gemcitabine

Docetaxel
Bevacizumab
VEGF

Study placed in the following topic categories:

Docetaxel
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma

Bevacizumab
Gemcitabine
Soft tissue sarcomas

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009