Chemotherapy and Radiation for Cutaneous Angiosarcoma

Not currently recruiting at 1 trial location

Overseen By Imran Zoberi, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Washington University School of Medicine

Must be taking: Paclitaxel

Must not be taking: Investigational agents

Disqualifiers: Other malignancy, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for cutaneous angiosarcoma, a rare and aggressive skin cancer. Researchers are testing the effectiveness of the chemotherapy drug paclitaxel (known by brand names such as Taxol, Onxol, and Abraxane) when combined with radiation therapy before surgery to remove the cancer. The goal is to determine if this combination can improve outcomes for patients with localized disease. Individuals diagnosed with cutaneous angiosarcoma who are currently undergoing or planning to begin weekly paclitaxel treatment might be suitable candidates for this study. As a Phase 1, Phase 2 trial, the study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but you must be receiving or planning to receive weekly paclitaxel treatment. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using paclitaxel with radiation therapy is generally safe and effective for treating cutaneous angiosarcoma, a type of skin cancer. Studies indicate that this combination can help patients live longer and usually does not cause severe side effects. For example, one study found that serious side effects were rare, making this treatment option promising.

Radiation therapy alone has also been studied for angiosarcoma. While most patients handle it well, some may develop skin ulcers as a side effect. In one study, serious skin issues occurred in about 1% of patients.

Overall, previous studies have shown that combining paclitaxel with radiation therapy is safe, with most patients experiencing no severe problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of paclitaxel and radiation therapy for cutaneous angiosarcoma because it brings a new approach to treating this rare cancer. Unlike traditional treatments that might rely solely on surgery or radiation, this method uses paclitaxel, a chemotherapy drug, alongside radiation to enhance its effectiveness. Paclitaxel helps to stop cancer cells from dividing, and when used with radiation, it can potentially increase the cancer-killing effects of the treatment. This combined strategy could offer better outcomes by shrinking tumors more effectively before surgery, making it a promising option for patients.

What evidence suggests that this trial's treatments could be effective for cutaneous angiosarcoma?

Research shows that paclitaxel, a type of chemotherapy, effectively treats angiosarcoma, especially when combined with radiation therapy. In this trial, all participants will receive paclitaxel and radiation therapy together. Studies have found that this combination leads to better outcomes for patients with cutaneous angiosarcoma, a rare and aggressive cancer. Patients receiving this treatment tend to live longer and experience more time without cancer progression compared to other treatments. Radiation therapy alone has also helped control localized angiosarcoma and improve survival rates. Overall, combining paclitaxel with radiation therapy offers promising results for treating this challenging cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Anthony Apicelli, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with measurable cutaneous angiosarcoma, a rare skin cancer. They must be fit enough for treatment (ECOG ≤1), agree to use contraception, and not have other recent cancers except certain skin cancers or cervical carcinoma in situ. Participants need to start radiotherapy within the first 7 weeks of weekly paclitaxel chemotherapy.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

I am starting or already on a weekly paclitaxel treatment and can start radiotherapy within 7 weeks of it.

Exclusion Criteria

I haven't had cancer, except for certain skin cancers or cervical pre-cancer, in the last 3 years.

I am HIV-positive with a CD4+ T-cell count below 350.

I do not have brain metastases or central nervous system disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive 6 weekly cycles of paclitaxel at 80 mg/m^2 as induction chemotherapy

6 weeks

Concurrent Chemoradiation

Participants receive 6 weekly cycles of paclitaxel at 80 mg/m^2 concurrently with radiation therapy (50.4 Gy in 28 fractions over 7 weeks)

7 weeks

Surgery

Standard of care surgery ideally within 6 weeks after completing concurrent chemotherapy and radiation therapy

6 weeks

Follow-up

Participants are monitored for overall survival and progression-free survival

2 years and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel
• Radiation therapy
• Research blood draw

Trial Overview

The study tests induction paclitaxel followed by concurrent chemoradiation therapy before surgical removal of the tumor. It aims to see if this approach improves outcomes in patients with localized disease who are typically treated with surgery alone.

How Is the Trial Designed?

Group I: Paclitaxel and Radiation Experimental Treatment 3 Interventions

* 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

Paclitaxel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in European Union as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in Canada as Paclitaxel for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A woman with non-small cell lung cancer developed a photodistributed dermatitis as a side effect of nab-paclitaxel therapy, which worsened with each treatment cycle, highlighting the potential for skin reactions in patients receiving taxane chemotherapy.

The patient's condition improved with topical corticosteroids and strict sun avoidance, indicating that while photodermatoses can occur with taxane treatments, they can be managed effectively without necessarily stopping chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nab-paclitaxel-associated photosensitivity: report in a woman with non-small cell lung cancer and review of taxane-related photodermatoses. Beutler, BD., Cohen, PR.[2020]

For patients with localized cutaneous angiosarcoma (cAS), wide-margin excision is recommended, and the use of preoperative and postoperative radiotherapy is suggested to address the tumor's tendency for local invasion.

In cases of metastatic cAS where surgery is not an option, treatments like radical radiotherapy or chemoradiotherapy may be considered, with paclitaxel being the first-line treatment, while new therapies such as targeted agents and immunotherapy are being explored for resistant tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Cutaneous Angiosarcoma: an Update Review. Bi, S., Zhong, A., Yin, X., et al.[2022]

In a study of 19 patients with localized angiosarcoma of the scalp, concurrent chemoradiation (CCRT) with maintenance chemotherapy using taxanes showed promising efficacy, with 1-year overall survival rates of 88% and 3-year rates of 52%.

The combination of CCRT and maintenance chemotherapy, along with surgical intervention, significantly improved progression-free survival, indicating that this treatment approach may be effective for patients without cervical lymph node metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single institutional experience of radiation therapy for angiosarcoma of the scalp without cervical lymph node metastases: Impact of concurrent chemoradiation with maintenance chemotherapy using taxanes on patient prognosis. Ihara, H., Kaji, T., Katsui, K., et al.[2020]

In a study of 25 patients with advanced cutaneous angiosarcoma (CAS) who had previously been treated with taxanes, eribulin mesylate demonstrated a median overall survival of 8.6 months and a response rate of 20%, suggesting it may be a viable second-line treatment option.

Despite the promising efficacy, caution is advised due to the occurrence of severe adverse events in over half of the participants, although all patients recovered, indicating a need for careful monitoring, especially in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of eribulin mesylate for patients with cutaneous angiosarcoma previously treated with taxane: a multicentre prospective observational study. Fujisawa, Y., Fujimura, T., Matsushita, S., et al.[2022]

Patients with cutaneous angiosarcoma receiving concurrent paclitaxel-based chemoradiotherapy (CRT) showed a significantly higher 2-year overall survival rate of 94.1% compared to 71.6% in those receiving other treatments, indicating the efficacy of CRT.

Despite no significant differences in local control, distant control, or progression-free survival between CRT and non-CRT groups, the promising overall survival results warrant further investigation in a prospective phase 2 trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent paclitaxel and radiation therapy for the treatment of cutaneous angiosarcoma. Roy, A., Gabani, P., Davis, EJ., et al.[2022]

In a study of 90 Japanese patients with cutaneous angiosarcoma, docetaxel showed equivalent overall survival and treatment duration compared to paclitaxel, suggesting it is a viable alternative for maintenance therapy.

While both treatments had adverse events, docetaxel was associated with a higher incidence of severe side effects (40.0%) compared to paclitaxel (23.6%), indicating a need for careful monitoring when using docetaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous angiosarcoma treated with taxane-based chemoradiotherapy: A multicenter study of 90 Japanese cases. Fujimura, T., Furudate, S., Maekawa, T., et al.[2023]

In a study of 50 Japanese patients with taxane-resistant cutaneous angiosarcoma (CAS), switching between taxanes (paclitaxel and docetaxel) showed a better safety profile compared to eribulin methylate and pazopanib, with fewer adverse events reported.

Although there was no significant difference in progression-free survival among the treatment regimens, the taxane-switch group experienced significantly lower rates of severe adverse events, suggesting it may be a safer option for second-line therapy in CAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for taxane-resistant cutaneous angiosarcoma: A multicenter study of 50 Japanese cases. Fujimura, T., Maekawa, T., Kato, H., et al.[2023]

In a retrospective study of 21 cases of cutaneous angiosarcoma (CAS), patients treated with paclitaxel combined with radiotherapy (PTX + RT) followed by maintenance chemotherapy had significantly better overall survival (28 months) and progression-free survival (12 months) compared to other treatments (10 months OS and 5 months PFS).

The findings support the use of PTX + RT followed by maintenance taxane chemotherapy as a superior treatment option for CAS, reinforcing previous research that indicated this approach is more effective than conventional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a combination of paclitaxel and radiation therapy against cutaneous angiosarcoma: A single-institution retrospective study of 21 cases. Seo, T., Kitamura, S., Yanagi, T., et al.[2022]

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