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SarcomaPhase 2NCT01104298

Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

A Phase 2 study testing Doxorubicin and Trabectedin in people with Sarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 20 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sarcoma
What is being tested?
Doxorubicin and Trabectedin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
20 sitesSpain
Study dates
Nov 2009to May 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must sign voluntarily the informed consent from before any study test is conducted that is not part of routine patient care, with the knowledge that he/she can abandon the study at any time without this affecting his/her previous care.
  • Aged between 18 and 70.
  • Pathological diagnosis of non operable and/or metastatic soft tissue sarcoma.
  • The following histological subtypes can be included:
  • Undifferentiated pleomorphic sarcoma (previously,malignant fibrous istiocytoma)
  • Leiomyosarcoma
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  • Angiosarcoma
  • Liposarcoma
  • Synovial sarcoma
  • Fibrosarcoma
  • Hemangiopericytoma
  • Neurofibrosarcoma
  • Mixofibrosarcoma
  • Unclassified sarcoma
  • Measurable disease, according to RECIST criteria
  • Performance status 0-2 Eastern Cooperative Oncology Group(ECOG).
  • Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, neutrophils ≥1.500/mm3, platelets ≥ 100.000/mm3). Patients with plasma creatinine ≤ 1,6 mg/dL, transaminases ≤2.5 times the upper limit of normal (ULN), total bilirubin ≤ upper limit of normal (ULN), CPK ≤ 2.5 times upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN) are acceptable. If the increase of alkaline phosphatase is > 2.5 times the upper limit of normal (ULN), then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ upper limit of normal (ULN).
  • 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.
  • Normal cardiac function with a Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or Multiple Uptake Gated Acquisition Scan (MUGA).

Who cannot join

  • Previous chemotherapy treatment.
  • Previous radiotherapy involving the only localization(s) of measurable tumoral disease.
  • Performance status> 2 Eastern Cooperative Oncology Group(ECOG).
  • Central Nervous System (CNS) metastases.
  • Plasma bilirubin > upper limit of normal(ULN).
  • Creatinine > 1.6 mg/dL.
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  • History of other neoplastic disease with the exception of basalioma or in situ cervical cancer adequately treated.
  • Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
  • Significant systemic diseases grade 3 or higher on the NCI-CTC version 3.0 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
  • Uncontrolled bacterial, mycotic or viral infections.
  • Women who are pregnant or breast-feeding
  • Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.
  • Patients participating in another clinical trial or receiving any other investigational product.
  • Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
  • The following histologic subtypes are excluded:
  • Rhabdomyosarcoma
  • Ewing's family of tumors
  • Desmoplastic small round cell tumor
  • Clear cell sarcoma
  • Alveolar sarcoma

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • ICO Badalona

    Badalona

  • H. Clinic Barcelona

    Barcelona

  • H. Sant Pau

    Barcelona

  • H. Provincial Castellón

    Castellon

  • ICO Girona

    Girona

  • Ico Hospitalet

    L'Hospitalet de Llobregat, Barcelona

  • H. Xeral Cies

    Lugo

  • Clinica Puerta Hierro

    Madrid

  • H. Clínico. San Carlos

    Madrid

  • H. U. La Paz

    Madrid

  • H.U. Gregorio Marañon

    Madrid

  • H.U. Ramon Y Cajal

    Madrid

  • H.U. Clinico de Malaga

    Málaga

  • H. de Navarra

    Navarra

  • H. C. Asturias

    Oviedo

  • H. Son Dureta

    Palma de Mallorca

  • H. Univ. Canarias

    Santa Cruz de Tenerife

  • H.U. Virgen Del Rocio

    Seville

  • Instituto Valenciano de Oncología

    Valencia

  • H. Miguel Servet

    Zaragoza

Other trials in Spain

About this study

Official title: Randomized, Open, Multicenter, Prospective, Phase II Clinical Trial of Doxorubicin vs. Trabectedin Plus Doxorubicin in the First Line Treatment of Patients With Advanced Non Operable and/or Metastatic Soft Tissue Sarcomas

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy

Read the detailed description

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy.

This proposal arises from the need to bring to the first line of treatment of advanced STS agents that have shown activity in second line. The goal is to improve available standard treatments. Tumors in patients not previously exposed to chemotherapy have not been selected in their biological behavior and they are the best scenario to test antitumor activity of a new anticancer drug.

The combination of drugs with different mechanisms of action may be a clear advantage to obtain better results and potential synergy. On the other hand, the toxicity profiles of both study drugs are different and worsening or summative of adverse effects is not expected.

The purpose of this study is to determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS).

Conditions
Sarcoma
Being tested
Doxorubicin, Trabectedin
Keywords
metastatic STS, Trabectedin, doxorrubicin, soft tissue sarcoma, non operable sarcoma
Medical subject headings
Sarcoma, Ichthyosis, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

    Also called Adriamycin

    A maximum of 6 cycles every 3 weeks of doxorubicin monotherapy 75 mg/square meter will be given in the absence of progression or not acceptable toxicity.

  • TrabectedinDrug

    Also called Yondelis

    A maximum of 6 cycles every 3 weeks of the combination (Trabectedin 1,1 mg/square meter + doxorubicin 60 mg/square meter) will be given in the absence of progression or not acceptable toxicity.

Study groups in NCT01104298
Study groupRoleWhat they receive
Arm AActive comparatorClassic Doxorubicin (Adriamycin - Doxorubicin hydrochloride) Presentation: Solution with 10, 20, or 50 mg Doxorubicin Hydrochloride. Excipients: hydrochloric acid and sodium chloride 0.9%, q.s. 25 ml. Pharmaceutical form: concentrate for solution for infusion. Route of administration: Intravenous
Receives: Drug: Doxorubicin
Arm BExperimentalTrabectedin Presentation: vials with trabectedin 1 mg and sucrose 400 mg. Pharmaceutical form: A white or whitish lyophilized powder as concentrate for solution for injection. Route of administration: for intravenous use after reconstitution and further dilution. Classic Doxorubicin (Adriamycin - Doxorubicin hydrochloride) Presentation: Solution with 10, 20, or 50 mg Doxorubicin Hydrochloride. Excipients: hydrochloric acid and sodium chloride 0.9%, q.s. 25 ml. Pharmaceutical form: concentrate for solution for infusion. Route of administration: Intravenous
Receives: Drug: Trabectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS)

    To determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS). To this end, progression free survival will be compared between both groups of treatment.

    Measured: 2012

Secondary outcomes (7)

  1. To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.

    To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.

    Measured: 2012

  2. To determine the tumor control (response rates plus stabilizations) in both arms of treatment.

    To determine the tumor control (response rates plus stabilizations) in both arms of treatment.

    Measured: 2012

  3. Overall survival.

    Overall survival.

    Measured: 2012

  4. To determine activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study).

    To determine activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study).

    Measured: 2012

  5. To determine toxicity of trabectedin/doxorubicin combination and the control arm.

    To determine toxicity of trabectedin/doxorubicin combination and the control arm.

    Measured: 2012

  6. To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters.

    To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters.

    Measured: 2012

  7. To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints.

    To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints.

    Measured: 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2012
  4. Study completionMay 2014

Why it stopped: Interim analysis did not show good results for main objective

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01104298
Sponsor's protocol ID
GEIS-20
Other IDs
2008-008922-55, 2008
Status last verified
Oct 2015
First submitted
13 Apr 2010
Last updated
27 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin and Trabectedin in people with Sarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Interim analysis did not show good results for main objective). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS) (time frame: 2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01104298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.

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