Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma

Who is this study for? Adult patients with Cutaneous Angiosarcoma
What treatments are being studied? Paclitaxel
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Angiosarcoma is a rare and aggressive form of soft tissue sarcoma. Prior work demonstrates very poor outcomes, with most patients developing metastatic disease and less than 50% surviving greater than 5 years. In other soft tissue sarcomas, the use of radiotherapy and/or chemotherapy have improved progression-free survival in patients undergoing limited, organ-sparing surgeries. Taxane chemotherapy has shown efficacy in patients with metastatic angiosarcoma, but this has not been tested in patients with localized disease. This study examines the efficacy of induction paclitaxel followed by concurrent chemoradiation therapy with paclitaxel prior to curative surgical resection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Anthony Apicelli, M.D.
apicella@wustl.edu
314-362-8610
Time Frame
Start Date: 2019-05-21
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 19
Treatments
Experimental: Paclitaxel and Radiation
* All patients will receive standard of care induction chemotherapy with 6 weekly cycles of paclitaxel at 80 mg/m\^2. They will then receive 6 weekly cycles of paclitaxel at 80 mg/m\^2 concurrently with radiation therapy. Patients will be receiving paclitaxel as part of their routine care, but in order to participate in this study, their induction chemotherapy regimen must be paclitaxel. Radiation therapy is 50.4 Gy in 28 fractions delivered within 7 weeks. A radiation therapy boost of 10-16.2 Gy over 5-9 fractions is allowed at the discretion of the treating physician.~* Standard of care surgery ideally within 6 weeks after completing concurrent chemotherapy and radiation therapy
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov