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CompletedNCT03275818ABRADESUpdated Jun 7, 2022

Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma

A Phase 2 interventional study of nab paclitaxel in Tumor, Desmoplastic Small Round Cell, Adult, Tumor, Desmoplastic Small Round Cell, Childhood and Sarcoma, Ewing, sponsored by Grupo Espanol de Investigacion en Sarcomas. Completed at 7 sites in Spain. Open to participants aged 6 Months to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-07.

Sponsored by Grupo Espanol de Investigacion en Sarcomas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
6 Months to 80 Years
Sex
All
01

Study summary

A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in Spain.

Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round cell tumor or Ewing sarcoma (DSRCT and ES)

Nab-paclitaxel (ABRAXANE) will be administered as follows:

Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days

Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason.

The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with improvement of pain with at least minimally important difference (MID) of 2 in subjects with desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT and ES cohort)

02

Conditions studied

  • Tumor, Desmoplastic Small Round Cell, Adult
  • Tumor, Desmoplastic Small Round Cell, Childhood
  • Sarcoma, Ewing
  • Sarcoma
  • Desmoid

Keywords

  • sarcoma
  • Desmoid tumor
  • Desmoplastic small round cell tumor
  • Ewing sarcoma
  • relapsed
  • refractory
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 69 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Grupo Espanol de Investigacion en Sarcomas is the lead sponsor of 20 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

TD Cohort

Inclusion Criteria:

  1. Subjects (parent or legal guardian if subject under 18 years) must voluntarily sign the form before any study test is conducted that is not part of routine subject care.
  2. Subjects with pathologic diagnosis of deep desmoid tumor of extremities, trunk wall or head and neck region.Intra-abdominal desmoid tumor cases could be enrolled if harboring betacatenin mutation.
  3. Subjects must be symptomatic (pain) due to tumor desmoid mass or lack physical function due to desmoid tumor mass, or in progression in the last 6 months.
  4. Age: ≥ 6 months.
  5. Subjects could have received one previous chemotherapy line if the scheme was methotrexate plus vinca alkaloids. Patients who received prostaglandin inhibitors or hormone therapy are also eligible.
  6. Availability of archive tumor block.
  7. , according to RECIST 1.1 criteria.
  8. Performance status ≤1 ().
  9. Normal values.
  10. Adequate bone marrow function ( ≥ 9 g/dL, leukocytes ≥ 3.000/mm3, neutrophils ≥ 1.500/mm3, ≥ 100.000/mm3). Subjects with plasma creatinine ≤ 1.6 mg/dl, transaminases ≤ 2.5 times the , total ≤ 1.25 times the ULN are acceptable.
  11. Men or women of must use an effective method of before entry into the study and throughout the same and for 6 months after ending the study treatment. Women of childbearing potential must have a negative urine or serum pregnancy test before study entry.
  12. and serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+) remaining at investigators' discretion the preventive treatment with lamivudine. If a potential subject is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the subject should NOT be included in the study (if a qualitative PCR cannot be performed then subject will not be able to enter the study).

Exclusion Criteria:

  1. Prior taxane therapy for any indication.
  2. Less than 4 weeks elapsed since prior exposure to chemotherapy.
  3. More than one previous chemotherapy line.
  4. Subjects with desmoid tumor of abdominal cavity (abdominal wall is not an exclusion criterion)
  5. Desmoid tumor with ill-defined margins.
  6. Unavailability to undergo MRI.
  7. Previously irradiated target lesion (if radiation dose exceeded 50 Gy).
  8. Pre-existing neuropathy greater than grade 1.
  9. Other active invasive requiring ongoing therapy or expected to require systemic therapy within two years. However, localized squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ of the cervix or other malignancies requiring only locally ablative therapy, will not result in exclusion.
  10. Concomitant anticancer therapy, immunotherapy or radiation therapy within prior 4 weeks.
  11. Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotic, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements
  12. Hb \< 9 g/dL.
  13. Women who are pregnant or breast-feeding.
  14. Known to protein bound paclitaxel
  15. Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol
  16. Known positive test for infection by (HIV).
  17. Subjects participating in another clinical trial or receiving any other product.

DSRCT and ES Cohort

Inclusion Criteria:

  1. Subjects or legal guardian must voluntarily sign the informed consent form before any study test is conducted that is not part of routine subject care.
  2. Subject diagnosed of desmoplastic small round cell tumor (DSRCT) or Ewing´s sarcoma.
  3. DSRCT subjects must have received at least one previous poli-chemotherapy line.
  4. Ewing´s sarcoma subjects must have received at least two standard chemotherapy lines.
  5. Age ≥ 6 months
  6. Availability of archive tumor blocks or slides (new recommended).
  7. Measurable disease, according to RECIST 1.1 criteria.
  8. Performance status ≤1 (ECOG).
  9. Adequate respiratory functions: > 1L.
  10. Normal ECG values.
  11. Adequate bone marrow function (hemoglobin ≥ 9 g/dL, leukocytes ≥ 3,000/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3). Subjects with plasma creatinine ≤ 1.6 mg/dL, transaminases ≤ 2.5 times the ULN, total bilirubin ≥ 1.25 times ULN, CPK ≤ 2.5 times ULN, alkaline phosphatase ≤ 2.5 times the ULN are acceptable. If alkaline phosphatase is > 2.5 times the ULN, then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ ULN.
  12. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.
  13. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+) remaining at investigators' discretion the preventive treatment with lamivudine. If a potential subject is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the subject should NOT be included in the study (if a qualitative PCR cannot be performed then subject will not be able to enter the study).
  14. Prior taxane therapy for any indication is accepted.
  15. > Grade 3 (intense and diffuse) expression of SPARC by immunohistochemistry.

Exclusion criteria:

  1. Less than 4 weeks elapsed since prior exposure to chemotherapy.
  2. Pre-existing neuropathy greater than Grade 1.
  3. Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years. However, localized squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ of the cervix or other malignancies requiring only locally ablative therapy, will not result in exclusion.
  4. Concomitant anticancer therapy, immunotherapy or radiation therapy within prior 4 weeks.
  5. Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotic, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements
  6. Hb \< 9 g/dL.
  7. Women who are pregnant or breast-feeding.
  8. Known hypersensitivity to protein bound paclitaxel.
  9. Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol.
  10. Known positive test for infection by human immunodeficiency virus (HIV).
  11. Subjects participating in another clinical trial or receiving any other investigational product.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    nab-paclitaxel

    nab-paclitaxel (ABRAXANE) will be administered as follows: * Age ≥ 21: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days * Age ≥ 6 months and ≤ 20 years: 240 mg/m2 (for patients weighing \> 10 kg) and 11.5 mg/kg (for patients weighing ≤ 10 kg) on days 1, 8 and 15 in cycles of 28 days

    Drug: nab paclitaxel

Interventions

  • Drugnab paclitaxel

    Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason

    Also known as: Abraxane

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR) - cohort 1

    TD cohort: Overall response rate (ORR) according to RECIST 1.1 and/or clinical benefit rate (CBR) at 3 months with pain improvement of at least 2 points in the Brief Pain Inventory - Short Form (BPI-SF)

    Time frame: 3 months

  2. Objective response rate (ORR) - cohort 2

    DSRCT and SE cohort: To determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing's sarcoma, using RECIST 1.1 criteria

    Time frame: 2 months

Secondary outcomes

  1. Pattern of radiological response - cohort 1

    TD cohort: To define the pattern of radiological response according to MRI parameters and to correlate it with CBR and Brief Pain Inventory (BPI) parameters.

    Time frame: 3 months

  2. Progression-free survival - cohort 1

    TD cohort: To estimate the efficacy of nab-paclitaxel as measured by the progression-free survival (PFS) assessed by median time.

    Time frame: 3 months

  3. Variation of symptoms - cohort 1

    TD cohort: To analyze the variation of symptoms during the first year from trial enrollment in accordance with BPI and Analgesic Quantification Algorithm (AQA).

    Time frame: during first year

  4. Variation of physical function - cohort 1

    TD cohort: To analyze the variation of physical function during the first year from trial enrollment in accordance with sponsor form.

    Time frame: during first year

  5. Safety profile of nab-paclitaxel - cohort 1

    TD cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.

    Time frame: up to 12 months

  6. Safety profile of nab-paclitaxel - cohort 2

    DSRCT and SE cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.

    Time frame: up to 12 months

07

Study locations

7 sites
  • H. de la Santa Creu i Sant Pau
    Barcelona, Spain
  • H. Sant Joan de Déu
    Barcelona, Spain
  • H.U. 12 de Octubre
    Madrid, Spain
  • H.U.Niño Jesús
    Madrid, Spain
  • H.U. Virgen del Rocío
    Sevilla, 41013, Spain
  • H.U i Politècnic La Fe
    Valencia, Spain
  • H.U. Miguel Servet
    Zaragoza, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Sep 2021, 52 months.

Of 335 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 99. This study's 52 months is below that.

Counting every sponsor, half of 514 studies reached it within 52 months; a quarter within 33 and three quarters within 92.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2017
First posted
Sep 8, 2017
StartActual
May 9, 2017
Primary completionActual
Sep 30, 2021
CompletionActual
Sep 30, 2021
Last update
Jun 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03275818
Lead sponsor
Grupo Espanol de Investigacion en Sarcomas
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
May 9, 2017
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Jun 7, 2022

Study contacts

Javier Martin Broto, MD
study director · Hospitales Universitarios Virgen del Rocío
Jaume Mora, MD
study director · Hospital Sant Joan de Deu
Javier Martínez Trufero, MD
principal investigator · Hospital Miguel Servet
Francisco Bautista, MD
principal investigator · Hospital Universitario Niño Jesús
Antonio López Pousa, MD
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Roberto Díaz, MD
principal investigator · Hospital Universitario La Fe
José Antonio López-Martín, MD
principal investigator · Hospital Universitario 12 de Octubre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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