TriangleNCT00245102 · REGISTRY CONDITION SEARCH
Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2014-05-23
This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically or cytologically confirmed sarcoma, including any of the following neoplastic subtypes: * Giant hemangioma * Angiosarcoma (including epithelioid hemangioendothelioma) * Malignant peripheral nerve sheath tumor * Leiomyosarcoma (closed to accrual as of 11/29/06) * High-grade undifferentiated pleomorphic sarcoma (i.e., malignant fibrous histiocytoma \[including myxofibrosarcoma\]) (closed to accrual as of 11/29/06) * Synovial sarcoma (closed to accrual as of 11/29/06) * Carcinosarcoma (closed to accrual as of 11/29/06) * Metastatic, locally advanced, or locally recurrent disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Lesions in a previously irradiated area may be considered measurable provided there is evidence of subsequent disease progression that cannot be attributed to necrosis or bleeding * No gastrointestinal stromal tumor * No known brain metastases * Performance status - ECOG 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No evidence of bleeding diathesis * Bilirubin ≤ 1.5 mg/dL * INR ≤ 1.5 * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No uncontrolled hypertension * No history of allergic reaction to compounds of similar chemical or biologic composition to sorafenib * No known HIV positivity * No active or ongoing infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric illness or social situation that would preclude study compliance * No swallowing dysfunction that would preclude the swallowing of tablets * Other malignancies allowed provided sarcoma is the primary disease requiring treatment * No other uncontrolled illness * No more than 1 prior chemotherapy regimen for recurrent or metastatic disease (≤ 3 regimens for angiosarcoma or malignant peripheral nerve sheath tumor) * Adjuvant chemotherapy completed \> 1 year prior to study entry is not considered a line of prior treatment * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * At least 3 weeks since prior radiotherapy * Recovered from prior antitumor therapy * Alopecia allowed * No prior sorafenib * No prior small molecule inhibitors of MAPK signaling intermediates * No concurrent therapeutic anticoagulation * Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial devices allowed provided requirements for PT, INR, or PTT requirements are met * No other concurrent investigational agents * No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) * No concurrent rifampin or Hypericum perforatum (St. John's wort)
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- intervention Names
- Drug: sorafenib tosylate
- label
- Arm I
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm I
- description
- Given orally
- name
- sorafenib tosylate
- other Names
- BAY 43-9006
- BAY 43-9006 Tosylate Salt
- BAY 54-9085
- Nexavar
- SFN
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 147
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.
- measure
- Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
- time Frame
- Up to 4 weeks
Full study description
- brief Summary
- This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
- detailed Description
- PRIMARY OBJECTIVES: I. The primary endpoint is the response rate (CR+PR) for each stratum of sarcoma patients treated with sorafenib as defined by RECIST. SECONDARY OBJECTIVES: I. Progression-free survival (defined as CR + PR + SD, assessed at 3 months or 6 months). II. Overall survival. III. Pharmacokinetics of sorafenib in this patient population (all sites will participate). IV. Frequency of B-raf mutations in the patients' sarcomas treated as part of this study and correlation with response or resistance to sorafenib (all sites will participate). V. Ras-raf kinase pathway activation in pre-treatment existing tumor specimens (paraffin section immunohistochemistry; all sites will participate). VI. At MSKCC only: Pre and post treatment specimen changes in downstream events of ras signaling, specifically inhibition of ERK phosphorylation. Only patients with angiosarcoma and MPNST will undergo biopsy (up to 10 patients). VII. At MSKCC only: Circulating Endothelial Cells (CECs), VE-cadherin levels, and soluble protein levels (VEGF, bFGF, endostatin) as a measures of angiogenesis before and after starting sorafenib therapy. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to sarcoma histology (angiosarcoma vs malignant peripheral nerve sheath tumor vs leiomyosarcoma \[closed to accrual as of 11/29/06\] vs high-grade undifferentiated pleomorphic sarcoma \[i.e., malignant fibrous histiocytoma (including myxofibrosarcoma)(closed to accrual as of 11/29/06)\] vs synovial sarcoma (closed to accrual as of 11/29/06) vs all other types of sarcoma). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed at 4 weeks.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice