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SarcomaPhase 2NCT00227669

Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma

A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Sarcoma, run by UNICANCER at 32 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Sarcoma
What is being tested?
docetaxel and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
32 sitesFrance
Study dates
Oct 2005to Aug 2012
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 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine or soft tissue leiomyosarcoma, meeting ≥ 1 of the following criteria:
  • Metastatic disease
  • Relapsed and unresectable disease
  • Prior treatment with a first-line anthracycline-based chemotherapy regimen required
  • Relapsed disease > 1 year after adjuvant chemotherapy is considered untreated disease
  • If relapsed disease occurs < 1 year after adjuvant therapy, then adjuvant therapy is considered a first-line treatment
  • At least 1 measurable lesion, defined as the following:
  • At least 1 target lesion must be located in a non-irradiated area
  • Obvious disease progression within the past 6 weeks
  • No other uterine sarcomas, including any of the following:
  • Carcinosarcoma
  • Endometrial stroma sarcoma
  • Other soft tissue sarcoma
  • No symptomatic or known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No specific hepatic contraindication to study treatment
  • Hepatitis B core and hepatitis B surface antigen negative

Renal

  • Creatinine < 1.5 times ULN
  • No specific renal contraindication to study treatment

Cardiovascular

  • No specific cardiac contraindication to study treatment

Immunologic

  • HIV negative
  • No specific allergic contraindication to study treatment
  • No active infection

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other serious underlying pathology that would preclude study treatment
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No neurotoxicity > grade 2
  • No psychological, sociological, or geographical condition that would preclude study compliance or follow-up schedule
  • No prior or concurrent psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No prior allogeneic graft or autologous graft

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No prior gemcitabine and/or taxane (i.e., docetaxel or paclitaxel)

Endocrine therapy

  • More than 4 weeks since prior hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to the only evaluable lesion

Surgery

  • Not specified

Other

  • No concurrent participation in another clinical trial using an experimental agent

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

France32 sites

  • Centre Hospitalier Universitaire d'Amiens

    Amiens, 80054

  • Centre Paul Papin

    Angers, 49036

  • C.H.G. Beauvais

    Beauvais, 60021

  • Institut Bergonie

    Bordeaux, 33076

  • C.H.U. de Brest

    Brest, 29609

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • CHU de la Timone

    Marseille, 13385

  • CHU Nord

    Marseille, 13915

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • CHR Hotel Dieu

    Nantes, 44093

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Cochin

    Paris, 75674

  • CHU Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma.

PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the anti-tumor activity, in terms of objective response rate, in patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma treated with gemcitabine with vs without docetaxel as second-line therapy.

Secondary

  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the response duration and overall survival of patients treated with these regimens.
  • Compare the tolerability and dose intensity of these regimens in these patients.
  • Determine biological markers with a predictive value for response to these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to location of leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4 weeks for 2-8 courses.
  • Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment repeats every 3 weeks for 2-8 courses.

PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be accrued for this study.

Conditions
Sarcoma
Keywords
uterine leiomyosarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, adult leiomyosarcoma
Medical subject headings
Sarcoma, Leiomyosarcoma

What participants receive

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

Study groups in NCT00227669
Study groupRoleWhat they receive
Arm I: GemcitabineActive comparatorGemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months
Receives: Drug: gemcitabine hydrochloride
Arm II: Gemcitabine + DocetaxelExperimentalGemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months
Receives: Drug: docetaxel; Drug: gemcitabine hydrochloride

What is being measured

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

  1. Anti-tumoral activity (objective response rate)

    Measured: 6 months

Secondary outcomes (6)

  1. Progression-free survival

    Measured: 6 months

  2. Response duration

    Measured: 3 years

  3. Tolerability

    Measured: 3 years

  4. Dose intensity

    Measured: 3 years

  5. Overall survival

    Measured: 3 years

  6. Biological markers

    Measured: 3 years

Timeline

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

  1. First posted28 Sep 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionFeb 2010
  4. Study completionAug 2012

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00227669
Sponsor's protocol ID
CDR0000443572
Other IDs
FRE-FNCLCC-SARCOME-07/0410, EU-20518
Status last verified
Aug 2016
First submitted
26 Sep 2005
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Individual participant data will not be shared at an individual level.

Publications

  • Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Sarcoma, run by UNICANCER at 32 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?

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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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?

Anti-tumoral activity (objective response rate) (time frame: 6 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 NCT00227669, 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 30 Aug 2016.

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