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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Docetaxel and Bevacizumab
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Soft Tissue Sarcoma, Phase I, Gemcitabine, Docetaxel, Bevacizumab, vascular endothelial growth factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (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.

Sites / Locations

  • Hematology Oncology Associates
  • University of New Mexico
  • St. Vincent Regional Medical Center
  • New Mexico Cancer Care Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

1000mg/m2 gemcitabine

1250 mg/m2 gemcitabine

1500 mg/m2 gemcitabine

Outcomes

Primary Outcome Measures

Overall response rate (complete and partial responses).
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses

Secondary Outcome Measures

Full Information

First Posted
January 11, 2006
Last Updated
June 17, 2015
Sponsor
New Mexico Cancer Care Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT00276055
Brief Title
Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
Official Title
Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Soft Tissue Sarcoma, Phase I, Gemcitabine, Docetaxel, Bevacizumab, vascular endothelial growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
1000mg/m2 gemcitabine
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
1250 mg/m2 gemcitabine
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
1500 mg/m2 gemcitabine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Docetaxel and Bevacizumab
Other Intervention Name(s)
Taxotere, Gemzar, Avastin
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall response rate (complete and partial responses).
Description
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Verschraegen, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology Oncology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-3661
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
St. Vincent Regional Medical Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87508
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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