Phase 2
Completed N=80
Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma
Source: ClinicalTrials.gov NCT00802880 ↗Enrolled (actual)
80
Serious AEs
20.0%
Results posted
Feb 2017
Primary outcomePrimary: Best Anatomical Tumor Response — 0; 2; 22; 30 participants
Summary
The purpose of this study is to determine the overall best tumor response rate to dacarbazine given until disease progression as assessed by RECIST criteria, CT and clinical exams in patients with metastatic sarcomas.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Anatomical Tumor Response |
0; 2; 22; 30 | — |
| SECONDARY Rate of Neutropenia (Grade 3/4) |
7.5 | — |
| SECONDARY Rate of Nausea/Emesis (Any Grade) |
22.5 | — |
| SECONDARY Comparison of the SUV at up to 3 Tumor Sites |
7.42; 7.57; 7.7; 6.89; 7.48 | — |
| SECONDARY Overall Tumor Metabolic Response |
0; 4; 13; 34 | — |
| SECONDARY Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate |
1; 0; 1; 2; 2; 10 | — |
| SECONDARY Overall Disease Control Rate |
0; 0; 5; 1 | — |
| SECONDARY Time to Progression (TTP) |
2.07 | — |
| SECONDARY Overall Survival |
8.09 | — |
| SECONDARY Correlate the Time to Progression With Best Anatomic Response |
NA; 4.14; 1.97 | — |
| SECONDARY Correlate Time to Progression With Best Metabolic Response |
3.95; 5.30; 2.07 | — |
| SECONDARY Correlate Overall Survival With Best Anatomic Response |
18.16; 14.77; 7.96 | — |
| SECONDARY Correlate Overall Survival With Best Metabolic Response |
18.16; 18.59; 8.75 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven diagnosis of soft tissue or bone sarcoma
- Metastatic or locally recurrent and unresectable sarcoma which progressed after one or more prior chemotherapy regimens (excluding adjuvant chemotherapy).
- At least one measurable tumor lesion (by CT scan) At least one FDG avid (SUV ≥ 3) tumor lesion (by PET/CT) which must have been performed at this institution. At least one of these target lesions must be ≥ 1.5 cm in smallest dimension as measured on the baseline CT
- Age greater than 18 yrs old
- ECOG Performance Status of 0-2
- Baseline ANC ≥ 1000/uL, Hgb ≥ 8 Gr/dL, platelets ≥ 100,000/ dL.
- Baseline serum creatinine 200 at time of PET scanning may need to reschedule to another day after consulting with appropriate physicians.)
Data sourced from ClinicalTrials.gov (NCT00802880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.