Treatment for cutaneous angiosarcoma using paclitaxel and radiation therapy
Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma
This study is testing if a combination of the chemotherapy drug paclitaxel and radiation therapy can help people with cutaneous angiosarcoma before they have surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03921008 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of induction paclitaxel followed by concurrent paclitaxel and radiation therapy in patients with cutaneous angiosarcoma. The approach aims to improve outcomes for patients with localized disease by combining chemotherapy and radiotherapy before surgical resection. Participants will receive weekly paclitaxel for 12 weeks, followed by radiation therapy, to assess the treatment's efficacy and safety. The study focuses on patients with measurable disease to evaluate the response to this combined treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed cutaneous angiosarcoma and measurable disease.
Not a fit: Patients with metastatic angiosarcoma or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for patients with cutaneous angiosarcoma.
How similar studies have performed: While taxane chemotherapy has shown efficacy in metastatic angiosarcoma, this specific approach in localized disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed cutaneous angiosarcoma. * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 5 mm with CT scan or ≥ 5 mm by clinical exam at the time of diagnosis * Currently receiving or planning to receive weekly paclitaxel for 12 weeks at 80 mg/m\^2 weekly. The patient must be able to begin radiotherapy within the first 7 weeks of paclitaxel treatment. * At least 18 years of age. * ECOG performance status ≤ 1 * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and one month after completion of the study * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon. * A history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * Currently receiving any investigational agents. * Current central nervous system disease or distant metastatic disease not including local-regional lymph nodes or satellite lesions. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Grade 2 or greater neuropathy * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or other agents used in the study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. * HIV-positive patients whose CD4+ T-cell count is \< 350 cells/mcL.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Anthony Apicelli, M.D. — Washington University School of Medicine
- Study coordinator: Anthony Apicelli, M.D.
- Email: apicella@wustl.edu
- Phone: 314-362-8610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.