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

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ClinicalTrials.gov Identifier: NCT03921008
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Angiosarcoma Drug: Paclitaxel Radiation: Radiation therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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.
  • Standard of care surgery ideally within 6 weeks after completing concurrent chemotherapy and radiation therapy
Drug: Paclitaxel
-Commercial supply
Other Name: Taxol

Radiation: Radiation therapy
-Patients may be treated with electrons, 3D conformal photon radiotherapy, intensity modulated photon radiotherapy (IMRT), proton radiation therapy, or a combination of these.




Primary Outcome Measures :
  1. Progression-free survival (PFS) rate [ Time Frame: 2 years following enrollment ]
    • PFS is defined as the duration of time from pathologic diagnosis to time of progression or death, whichever occurs first.
    • Progression is defined as the appearance of new angiosarcoma lesions as determined by clinical exam, radiography, and/or pathologic confirmation.


Secondary Outcome Measures :
  1. Overall survival (OS) rate [ Time Frame: At 2 years following enrollment ]
    -Patients that have died from any cause will be censored from the OS rate calculation

  2. Pathologic complete response rate (pCR) [ Time Frame: At the time of surgery (approximately 19 weeks) ]
    -Defined as the lack of viable cells observed in resected tumor tissue following neoadjuvant therapy and will be determined by an experienced sarcoma pathologist

  3. Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0 [ Time Frame: Through 90 days of completing treatment ]
  4. Rate of late treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0 [ Time Frame: At 2 years following enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921008


Contacts
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Contact: Matthew Spraker, M.D. 314-362-8567 mspraker@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Matthew Spraker, M.D.    314-362-8567    mspraker@wustl.edu   
Principal Investigator: Matthew Spraker, M.D.         
Sub-Investigator: Prashant Gabani, M.D.         
Sub-Investigator: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Ryan Jackson, M.D.         
Sub-Investigator: Jason Rich, M.D.         
Sub-Investigator: Brian Baumann, M.D.         
Sub-Investigator: Jeff Michalski, M.D., M.B.A         
Sub-Investigator: Imran Zoberi, M.D.         
Sub-Investigator: Leping Wan, M.P.H.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Matthew Spraker, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03921008     History of Changes
Other Study ID Numbers: 201904069
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action