Therapy of Angiosarcomas with standard therapy paclitaxel in combination with pazopanib (Votrient)
- Conditions
- Advanced and relapsed angiosarcomaMedDRA version: 18.1Level: LLTClassification code 10002481Term: Angiosarcoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10072814Term: Breast angiosarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10072813Term: Breast angiosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10025223Term: LymphangiosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: HLTClassification code 10025224Term: LymphangiosarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10057700Term: Angiosarcoma non-metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10002480Term: Angiosarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: LLTClassification code 10018827Term: HaemangiosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10072891Term: Skin angiosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2012-005846-39-DE
- Lead Sponsor
- niversity of Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
Note: Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging studies) and obtained prior to signing informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
2. Age = 18 years
3. Life expectancy > 3 months
4. Ability to swallow tablets
5. Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g. radiation-induced or angiosarcoma in chronical lymphedema) are eligible.
6. Tumor must be locally advanced (unresectable) or metastatic. A progression must be documented within a 6-month period prior to screening.
7. ECOG performance status = 2
8. At least one measurable skin lesion or one measurable radiological (CT or MRI) target lesion (RECIST 1.1)
9. Adequate organ system function as described in protocoll
10. A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use adequate contraception (as defined in protocol) during the study and for 6 month after the last dose of study drug.
11. All sexually active male patients must agree to use adequate methods of birth control (see protocol) throughout the study and for 6 month after the last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
1. Patients who need an active treatment for another malignant disease other than angiosarcoma
2. Prior treatment with a taxan within the last 12 months before study entry
3. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal sarcomatosis
4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
6. Presence of uncontrolled infection
7. QT prolongation interval (QTc) > 480 msecs
8. Clinically significant cardiovascular discorders within the past 6 months
9. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
10. Poorly controlled hypertension (see protocol)
11. Evidence of active bleeding or bleeding diathesis
12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
13. Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put patient safety at risk, prevent giving informed consent or impact the patient's compliance with the use of study medication
14. Women who are pregnant or breast feeding
15. Patients who are not able or not willing to interrupt the intake of medications that are not allowed according to study protocol for at least 14 days before start of study medication and for the whole study period
16. Chemotherapy or radiotherapy within 14 days before start of study medication
17. Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Please note: Any treatment with Pazopanib before study entry is NOT allowed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate progression free survival at 6 month (PFS-R);Secondary Objective: to evaluate response rate according to RECIST 1.1, overall survival and assessment of safety aspects;Primary end point(s): rate of progression free survival at 6 month (PFS-R);Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival (OS)<br>Response Rate (RR rate according to RECIST Version 1.1)<br>Toxicity (according to CTCAE, Version 4.0);Timepoint(s) of evaluation of this end point: during study is running