LeiomyosarcomaPhase 2LMS03NCT01442662
Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine
A Phase 2 study testing pazopanib + gemcitabine in people with Leiomyosarcoma, run by UNICANCER at 17 sites in France.
Trial summary
The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leiomyosarcoma
- What is being tested?
- pazopanib + gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 17 sitesFrance
- Study dates
- Sep 2011to 28 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of metastatic or relapsed of uterine or soft tissue leiomyosarcoma previously treated with one line of chemotherapy with at least an anthracycline. Patients who have received adjuvant therapy less than one year before relapse were considered to have received a first line therapy for metastatic disease)
- Delay between the end of previous treatment (chemotherapy, hormonotherapy, radiotherapy, immunotherapy, surgery or tumor embolisation) must be > 4 weeks
- At least one measurable lesion with RECIST criteria with progressive disease between the last 6 weeks between inclusion. One target at least must be in a non irradiated area
- performance status ECOG ≤ 2
- Age ≥ 18 years
- Subjects must provide written informed consent prior to performance of study-specific procedures, and must be willing to comply with treatment and follow up
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- Adequate hematologic function
- Adequate coagulation function
- Adequate renal function
- Adequate liver function
- Patients must be affiliated to a Social Health Insurance
- Women of childbearing potential must be using a medically accepted method of contraception and must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the first study treatment.
- LVEF ≥ site limits
- Main Exclusion Criteria:
- Other uterine or soft tissue sarcomas
- Symptomatic or known brain metastasis
- Radiation therapy on the only evaluable lesion
- Anti coagulant treatment
- strong inhibitors or inducers of the isoenzyme CYP3A4 treatment
- Known sero-positivity (HIV, HbC, HbS)or uncontrolled infection
- other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Clinically significant gastrointestinal abnormalities that may affect the absorption of the IP
- Corrected QT interval > 480 msec
- Other serious underlying pathology that would preclude study treatment
- Calcium and magnesium levels inferior to standard levels (measured within 14 days before the first pazopanib dose) and potassium levels inferior to standard levels (measured within 72 hours before the first pazopanib dose)
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre G.F Leclerc
Dijon, 21034
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13273
CHU Timone
Marseille, 13385
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298
Institut de Cancérologie de l'Ouest/Centre René Gauducheau
Nantes Saint Herblain, 44806
Centre Antoine Lacassagne
Nice, 06189
Institut Curie - Hôpital Claudius Regaud
Paris, 75005
Centre Henri Becquerel
Rouen, 76038
Institut Curie - Hopital René Huguenin
Saint-Cloud, 92210
Institut Claudius Regaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas
The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.
Read the detailed description
Primary Objectives:
To determine the PFS using combination of gemcitabine and pazopanib in patients with metastasis or relapse leiomyosarcoma (uterine or soft tissue)who have already received s first line anthracycline based therapy.
Secondary objectives:
To determine the disease control rate To determine the response rate To determine toxicities associated with combined gemcitabine and pazopanib To determine correlation between metabolic response and PFS
Design:
All eligible patients entering the study will receive daily oral pazopanib at 800mg, supplied as 200 mg aqueous film-coated tablets and 2 intravenous gemcitabine every three weeks (8 cycles max).
The treatment will continue until the development of unacceptable toxicity or evidence of disease progression or until patient's / investigator's decision of withdrawal.
- Conditions
- Leiomyosarcoma
- Being tested
- pazopanib + gemcitabine
- Keywords
- Metastatic or relapsed uterine or soft tissue leiomyosarcoma
- Medical subject headings
- Leiomyosarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pazopanib + gemcitabineDrug
pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle
| Study group | Role | What they receive |
|---|---|---|
| pazopanib, gemcitabine | Experimental | pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle Receives: Drug: pazopanib + gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To assess the 9-month Progression Free Survival in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas and treated with Gemcitabine and Pazopanib
Measured: 9 months
Secondary outcomes (3)
disease control rate and overall response rate
Measured: 12 weeks
Safety of the combination Gemcitabine-Pazopanib
The severity of the adverse events and toxicity will be graded according to the NCI CTC-AE v4.0
Measured: during the entire trial
metabolic response by using PET scan
First PET scan at baseline and the second one at 6 weeks after the first administration
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2018
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Pautier, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442662
- Sponsor's protocol ID
- SARCOME 11/1101
- Other IDs
- 2011-001308-36
- Acronym
- LMS03
- Status last verified
- Jan 2020
- First submitted
- 10 Aug 2011
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: PD will not be shared at an individual level, they will be part of the study database including all enrolled patients
Publications
Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.
PubMed 31835236
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas
- ClinicalTrials.gov ID
- NCT01442662
- Acronym / sponsor ID
- LMS03 / SARCOME 11/1101
- Conditions
- Leiomyosarcoma
- Keywords
- Metastatic or relapsed uterine or soft tissue leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.
Detailed description
Primary Objectives:
To determine the PFS using combination of gemcitabine and pazopanib in patients with metastasis or relapse leiomyosarcoma (uterine or soft tissue)who have already received s first line anthracycline based therapy.
Secondary objectives:
To determine the disease control rate To determine the response rate To determine toxicities associated with combined gemcitabine and pazopanib To determine correlation between metabolic response and PFS
Design:
All eligible patients entering the study will receive daily oral pazopanib at 800mg, supplied as 200 mg aqueous film-coated tablets and 2 intravenous gemcitabine every three weeks (8 cycles max).
The treatment will continue until the development of unacceptable toxicity or evidence of disease progression or until patient's / investigator's decision of withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pazopanib, gemcitabine | Experimental | Drug: pazopanib + gemcitabinepazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed diagnosis of metastatic or relapsed of uterine or soft tissue leiomyosarcoma previously treated with one line of chemotherapy with at least an anthracycline. Patients who have received adjuvant therapy less than one year before relapse were considered to have received a first line therapy for metastatic disease)
- Delay between the end of previous treatment (chemotherapy, hormonotherapy, radiotherapy, immunotherapy, surgery or tumor embolisation) must be > 4 weeks
- At least one measurable lesion with RECIST criteria with progressive disease between the last 6 weeks between inclusion. One target at least must be in a non irradiated area
- performance status ECOG ≤ 2
- Age ≥ 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pazopanib + gemcitabinepazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle | Drug | pazopanib, gemcitabine |
Primary outcome
Progression Free Survival
Time frame: 9 months
To assess the 9-month Progression Free Survival in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas and treated with Gemcitabine and Pazopanib
3 secondary outcomes
disease control rate and overall response rate
Time frame: 12 weeks
Safety of the combination Gemcitabine-Pazopanib
Time frame: during the entire trial
metabolic response by using PET scan
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 31835236Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.
- Individual participant dataSharing planned: No. PD will not be shared at an individual level, they will be part of the study database including all enrolled patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Pautier, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pazopanib + gemcitabine in people with Leiomyosarcoma, run by UNICANCER at 17 sites in France.
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 25 inclusion and 0 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: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression Free Survival (time frame: 9 months). 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 NCT01442662, which also lists 1 linked publication.
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 31 Jan 2020.