Paclitaxel for Skin Angiosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Skin Angiosarcoma+2 MorePaclitaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effectiveness of two drugs, paclitaxel and cabozantinib, in treating patients with soft tissue sarcoma. The first group of patients will receive paclitaxel, and the second group will receive paclitaxel and cabozantinib. The trial is being done to see if the combination of the two drugs can shrink the tumor and prevent it from coming back.

Eligible Conditions
  • Visceral Angiosarcoma
  • Skin Angiosarcoma
  • Skin Radiation-Related Angiosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 3 years

At 6 months
PFS rate
Year 3
Progression free survival (PFS) in taxane naive patients with angiosarcoma
Year 3
Overall survival in each of the 2 combination arms
Up to 3 years
Incidence of adverse events
ORR in the nivolumab + paclitaxel
Overall response rate (ORR) in angiosarcoma patients who have had prior taxane
Patient-reported outcomes (PRO)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Headache
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Pigmentation disorder
6%Insomnia
6%Transaminases increased
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

3 Treatment Groups

Arm I (nivolumab, paclitaxel)
1 of 3
Arm II (paclitaxel)
1 of 3
Arm III (nivolumab, cabozantinib S-malate)
1 of 3

Experimental Treatment

90 Total Participants · 3 Treatment Groups

Primary Treatment: Paclitaxel · No Placebo Group · Phase 2

Arm I (nivolumab, paclitaxel)Experimental Group · 4 Interventions: Questionnaire Administration, Nivolumab, Paclitaxel, Quality-of-Life Assessment · Intervention Types: Other, Biological, Drug, Other
Arm II (paclitaxel)Experimental Group · 3 Interventions: Questionnaire Administration, Paclitaxel, Quality-of-Life Assessment · Intervention Types: Other, Drug, Other
Arm III (nivolumab, cabozantinib S-malate)Experimental Group · 4 Interventions: Questionnaire Administration, Cabozantinib S-malate, Nivolumab, Quality-of-Life Assessment · Intervention Types: Other, Drug, Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Nivolumab
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,085 Previous Clinical Trials
41,141,421 Total Patients Enrolled
Juneko E Grilley-OlsonPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of childbearing potential.
You have a performance status of 0 or 1.
Patient must have completed all prior cancer directed therapies (including investigational) > 7 days prior to cycle 1 day 1.
You have diagnostic slides and 5 x 4-6 micron unstained slides from diagnostic tumor tissue.
The following criteria must be met for a lesion to be considered measurable:\n- Size: The lesion must be palpable and measurable.\n- Location: The lesion must be superficial and be located on the skin.\n- Shape: The lesion must be round or oval.\n- Margins: The lesion must have a clear margin.\n- Size: The lesion must be ≥ 10 mm in diameter.\n- Size: The lesion must be ≥ 10 mm in diameter.
You are not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.