Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre Oscar Lambret
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00874874
First received: April 2, 2009
Last updated: December 23, 2009
Last verified: July 2009
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Purpose
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: sorafenib tosylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Rate of non-progression at 9 months by RECIST criteria [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate.
Secondary
- Determine the rate of non-progression at 60, 120, and 180 days.
- Determine the median time to progression.
- Determine overall survival.
- Determine the best response rate.
- Determine the clinical and biological factors that predict clinical benefit.
- Evaluate tolerability by NCI CTCAE v3.0.
- Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis.
- Explore the tumor expression of these genes in tissue from a tumor bank.
OUTLINE: This is a multicenter study.
Patients are stratified according to disease type (cutaneous angiosarcoma [scalp, breast, or soft tissue] vs visceral angiosarcoma). All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed angiosarcoma
- Locally advanced or metastatic disease
- Unresectable disease
- No Kaposi sarcoma, hemangiopericytoma, or hemangioendothelioma
- Measurable tumor with at least 1 measurable lesion by RECIST criteria
- Tumor in a previously irradiated area must not show progression
- No brain metastases or meningeal tumors (symptomatic or asymptomatic)
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
PT or INR and aPTT ≤ 1.5 times upper limit of normal (ULN)
- Anticoagulation treatment with heparin or vitamin K allowed if the above criteria are met
- Liver transaminases ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN
- Serum creatinine ≤ 1.5 times ULN
- Amylase and lipase ≤ 1.5 times ULN
- Not pregnant or nursing
- Weight loss from pre-disease weight < 20% over the past 12 months
- Able to swallow
- No active or ischemic coronary artery disease
- No myocardial infarction within the past 6 months
- No NYHA class III-IV cardiac failure
- No uncontrolled hypertension
- No coagulopathy
- No active uncontrolled peptic ulcer
- No patients on renal dialysis
- No active bacterial or fungal infection > CTCAE v3.0 grade 2
- No HIV or hepatitis B or C positivity
- No chronic unstable illness that could jeopardize patient safety or compliance
- No other progressive or malignant tumor
- No known or suspected allergy to sorafenib tosylate
- No psychological, familial, social, or geographic situations that preclude clinical follow up
- No patients deprived of liberty or under guardianship
- No cardiac arrhythmia requiring antiarrhythmic medication (except beta-blockers or digoxin for chronic atrial fibrillation)
- No epilepsy requiring antiepileptic drugs
PRIOR CONCURRENT THERAPY:
- See Patient Characteristics
- No prior organ or peripheral stem cell transplantation
- No more than 2 prior lines of chemotherapy
- At least 28 days since prior treatment (systemic or major surgery)
- No concurrent therapy for another malignancy
- No concurrent CYP3A inducers (e.g., rifampicin, St. John wort, phenytoin, carbamazepine, phenobarbital, dexamethasone)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874874
Locations
| France | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Nicolas Penel, MD 33-3-20-295-920 | |
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
| Principal Investigator: | Nicolas Penel, MD | Centre Oscar Lambret |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00874874 History of Changes |
| Other Study ID Numbers: | CDR0000633547, COL-Angio-Next, BAYER-COL-Angio-Next, COL-2007-10, INCA-RECF0636, EUDRACT-2007-004651-10 |
| Study First Received: | April 2, 2009 |
| Last Updated: | December 23, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma recurrent adult soft tissue sarcoma adult angiosarcoma |
Additional relevant MeSH terms:
|
Hemangiosarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Sorafenib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013