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

Primary Purpose

Cutaneous Angiosarcoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Paclitaxel

Radiation therapy

Research blood draw

About this trial

This is an interventional treatment trial for Cutaneous Angiosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel and Radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) rate

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

Overall survival (OS) rate

-Patients that have died from any cause will be censored from the OS rate calculation

Pathologic complete response rate (pCR)

-Defined as the lack of viable cells observed in resected tumor tissue following neoadjuvant therapy and will be determined by an experienced sarcoma pathologist

Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0

Rate of late treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0

Full Information

NCT ID

NCT03921008

First Posted

April 16, 2019

Last Updated

May 30, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03921008

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 21, 2019 (Actual)

Primary Completion Date

August 31, 2026 (Anticipated)

Study Completion Date

August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Angiosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel and Radiation

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

-Commercial supply

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Research blood draw

Intervention Description

-Within 1 week (prior to cycle 1 of paclitaxel preferred but not required), pre-radiation therapy (any time weeks 5-7 as long as radiation therapy has not started), post-radiation therapy (day of last fraction), 14 days post-radiation therapy, and within 2 weeks post-surgery

Primary Outcome Measure Information:

Title

Progression-free survival (PFS) rate

Description

Time Frame

At year 2 follow-up (estimated to be 2 years and 12 weeks)

Secondary Outcome Measure Information:

Title

Overall survival (OS) rate

Description

-Patients that have died from any cause will be censored from the OS rate calculation

Time Frame

At year 2 follow-up (estimated to be 2 years and 12 weeks)

Title

Pathologic complete response rate (pCR)

Description

-Defined as the lack of viable cells observed in resected tumor tissue following neoadjuvant therapy and will be determined by an experienced sarcoma pathologist

Time Frame

At the time of surgery (approximately 19 weeks)

Title

Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0

Time Frame

From start of radiation through 90 days after start of radiation

Title

Rate of late treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0

Time Frame

From 91 days through year 2 follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony Apicelli, M.D.

Phone

314-362-8610

apicella@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Apicelli, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anthony Apicelli, M.D.

Phone

314-362-8610

apicella@wustl.edu

First Name & Middle Initial & Last Name & Degree

Anthony Apicelli, M.D.

First Name & Middle Initial & Last Name & Degree

Brian Van Tine, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Ryan Jackson, M.D.

First Name & Middle Initial & Last Name & Degree

Jason Rich, M.D.

First Name & Middle Initial & Last Name & Degree

Jeff Michalski, M.D., M.B.A

First Name & Middle Initial & Last Name & Degree

Yi Huang, M.S.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33604458

Citation

Roy A, Gabani P, Davis EJ, Oppelt P, Merfeld E, Keedy VL, Zoberi I, Chrisinger JSA, Michalski JM, Van Tine B, Spraker MB. Concurrent paclitaxel and radiation therapy for the treatment of cutaneous angiosarcoma. Clin Transl Radiat Oncol. 2021 Jan 28;27:114-120. doi: 10.1016/j.ctro.2021.01.009. eCollection 2021 Mar.

Results Reference

derived

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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

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