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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00276055
First received: January 11, 2006
Last updated: April 30, 2013
Last verified: April 2013
History of Changes

January 11, 2006
April 30, 2013
November 2005
November 2010   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00276055 on ClinicalTrials.gov Archive Site
Not Provided
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Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma

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

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: Gemcitabine, Docetaxel and Bevacizumab
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
Other Names:
  • Taxotere
  • Gemzar
  • Avastin
  • Experimental: Cohort 1
    1000mg/m2 gemcitabine
    Intervention: Drug: Gemcitabine, Docetaxel and Bevacizumab
  • Experimental: Cohort 2
    1250 mg/m2 gemcitabine
    Intervention: Drug: Gemcitabine, Docetaxel and Bevacizumab
  • Experimental: Cohort 3
    1500 mg/m2 gemcitabine
    Intervention: Drug: Gemcitabine, Docetaxel and Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00276055
INST 0509C
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Claire Verschraegen, MD University of New Mexico
New Mexico Cancer Care Alliance
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP