- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276055
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico
-
Albuquerque, New Mexico, United States, 87102-3661
- Hematology Oncology Associates
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Santa Fe, New Mexico, United States, 87505
- St. Vincent Regional Medical Center
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Santa Fe, New Mexico, United States, 87508
- New Mexico Cancer Care Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
1000mg/m2 gemcitabine
|
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:
|
Experimental: Cohort 2
1250 mg/m2 gemcitabine
|
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:
|
Experimental: Cohort 3
1500 mg/m2 gemcitabine
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (complete and partial responses).
Time Frame: 4 years
|
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
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claire Verschraegen, MD, University of New Mexico
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Docetaxel
- Bevacizumab
Other Study ID Numbers
- INST 0509C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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