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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 1000mg/m2 gemcitabine |
|
| Cohort 2 | Experimental | 1250 mg/m2 gemcitabine |
|
| Cohort 3 | Experimental | 1500 mg/m2 gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine, Docetaxel and Bevacizumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 years |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Verschraegen, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates | Albuquerque | New Mexico | 87102-3661 | United States | ||
| University of New Mexico |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
|
| Albuquerque |
| New Mexico |
| 87131 |
| United States |
| St. Vincent Regional Medical Center | Santa Fe | New Mexico | 87505 | United States |
| New Mexico Cancer Care Associates | Santa Fe | New Mexico | 87508 | United States |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |