Trial Outcomes & Findings for Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07) (NCT NCT00330421)
NCT ID: NCT00330421
Last Updated: 2014-04-30
Results Overview
Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
COMPLETED
PHASE2
15 participants
Baseline to up to 1 month post-treatment
2014-04-30
Participant Flow
This phase II study enrolled pts with metastatic or inoperable sarcomas. Additional eligibility criteria: at least one site of measurable disease, at least one superficial palpable tumor (\>1cm) amenable to biopsy, age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and no prior sorafenib therapy.
Additional eligibility criteria included: at least one site of measurable disease by radiologic imaging, at least one superficial palpable tumor (\>1cm) with no overlying viscera amenable to biopsy, age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and no prior sorafenib therapy.
Participant milestones
| Measure |
Group II (Metastatic or Inoperable Sarcomas)
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies
|
Group I (Sarcomas of Extremity)
Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
0
|
|
Overall Study
COMPLETED
|
15
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07)
Baseline characteristics by cohort
| Measure |
Group II (Metastatic or Inoperable Sarcomas)
n=15 Participants
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 15 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 1 month post-treatmentPaired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to up to 1 month post-treatmentPopulation: IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.
Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Outcome measures
| Measure |
Group II (Metastatic or Inoperable Sarcomas)
n=2 Participants
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies
|
|---|---|
|
Change in Interstitial Fluid Pressure (IFP)
|
4.25 mm Hg
Interval 3.0 to 5.5
|
PRIMARY outcome
Timeframe: Baseline to up to 1 month post-treatmentPaired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to up to 1 month post-treatmentPaired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to surgeryOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 monthOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 monthOutcome measures
Outcome data not reported
Adverse Events
Group II (Metastatic or Inoperable Sarcomas)
Serious adverse events
| Measure |
Group II (Metastatic or Inoperable Sarcomas)
n=15 participants at risk
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies
|
|---|---|
|
General disorders
Fatigue
|
73.3%
11/15 • Number of events 22
|
|
Blood and lymphatic system disorders
Hemoglobin
|
53.3%
8/15 • Number of events 16
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
46.7%
7/15 • Number of events 16
|
|
Hepatobiliary disorders
AST
|
46.7%
7/15 • Number of events 16
|
|
Blood and lymphatic system disorders
Hematologic - other
|
40.0%
6/15 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
6/15 • Number of events 11
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
5/15 • Number of events 11
|
|
General disorders
Anorexia
|
33.3%
5/15 • Number of events 10
|
Other adverse events
| Measure |
Group II (Metastatic or Inoperable Sarcomas)
n=15 participants at risk
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies
|
|---|---|
|
General disorders
Hand-foot reaction
|
46.7%
7/15 • Number of events 21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60