LeiomyosarcomaPhase 2NCT00282087
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
A Phase 2 study testing gemcitabine, docetaxel, doxorubicin in people with Leiomyosarcoma and Uterine Neoplasm, run by Sarcoma Alliance for Research through Collaboration at 12 sites in United States.
Trial summary
The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyosarcoma, Uterine Neoplasm
- What is being tested?
- gemcitabine, docetaxel, doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2006to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- high risk uterine LMS, FIGO stage I or II
- pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
- no longer than 12 weeks from surgical resection of cancer
- no evidence of residual disease
- ECOG 0 or 1
Show all 12Show fewer
- ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000
- creatinine ≤ 1.5 x institutional upper limits of normal
- adequate liver function
- neuropathy (sensory and motor) ≤ CTC grade 1
- negative pregnancy test
- signed consent
Who cannot join
- patients with other invasive malignancies
- prior therapy with gemcitabine or docetaxel or doxorubicin
- hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- women who are breast feeding
- cardiac ejection fraction <50%
- prior pelvic irradiation
- treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48109
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30308
Dana Farber Cancer Institute
Boston, Massachusetts, 01225
Massachusetts General
Boston, Massachusetts, 02114
University of Chicago
Chicago, Illinois, 60637
MD Anderson Cancer Center
Houston, Texas, 77030
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, 46260
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Washington Cancer Institute/Washington Hospital Center (Medstar)
Washington D.C., District of Columbia, 20010
About this study
Official title: Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.
Read the detailed description
Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.
- Conditions
- Leiomyosarcoma, Uterine Neoplasm
- Being tested
- gemcitabine, docetaxel, doxorubicin
- Keywords
- early stage, high grade, uterine leiomyosarcoma, adjuvant treatment
- Medical subject headings
- Leiomyosarcoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, docetaxel, doxorubicinDrug
Cycles = 28 days
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine/docetaxel then doxorubicin | Other | Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access). Receives: Drug: gemcitabine, docetaxel, doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
Measured: Every 3 months up to two years
Secondary outcomes (9)
Tolerability/Toxicity of This Regimen
Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
Measured: Every 28 days during dosing and then every 3 months thereafter until patient comes off study
Correlation Between Age and Tumor Response to Treatment (PFS)
Measured: 2 years
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
Measured: 2 years
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
Measured: 2 years
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
Mitotic rate is measured in mitoses per 10 high-power fields
Measured: 2 years
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
Measured: 2 years
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
Measured: 2 years
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)
Measured: 2 years
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martee L. Hensley, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282087
- Sponsor's protocol ID
- SARC005
- Other IDs
- MSKCC05-128
- Status last verified
- Nov 2014
- First submitted
- 24 Jan 2006
- Last updated
- 1 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18.
PubMed 23335221
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00282087
- Acronym / sponsor ID
- SARC005
- Conditions
- Leiomyosarcoma, Uterine Neoplasm
- Keywords
- early stage, high grade, uterine leiomyosarcoma, adjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sarcoma Alliance for Research through CollaborationUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.
Detailed description
Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine/docetaxel then doxorubicin | Other | Drug: gemcitabine, docetaxel, doxorubicinGemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 18 years of age
- high risk uterine LMS, FIGO stage I or II
- pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
- no longer than 12 weeks from surgical resection of cancer
- no evidence of residual disease
Key exclusion criteria (7 listed)
- patients with other invasive malignancies
- prior therapy with gemcitabine or docetaxel or doxorubicin
- hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- women who are breast feeding
- cardiac ejection fraction <50%
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 |
|---|---|---|
| gemcitabine, docetaxel, doxorubicinCycles = 28 days | Drug | gemcitabine/docetaxel then doxorubicin |
Primary outcome
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
Time frame: Every 3 months up to two years
9 secondary outcomes
Tolerability/Toxicity of This Regimen
Time frame: Every 28 days during dosing and then every 3 months thereafter until patient comes off study
Correlation Between Age and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
Time frame: 2 years
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23335221Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18.
- SARC WebsiteLink provided by the sponsor.
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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.
Martee L. Hensley, MD principal investigator
Memorial Sloan Kettering Cancer Center
12 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 gemcitabine, docetaxel, doxorubicin in people with Leiomyosarcoma and Uterine Neoplasm, run by Sarcoma Alliance for Research through Collaboration at 12 sites in United States.
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 12 inclusion and 7 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 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS (time frame: Every 3 months up to two years). 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 NCT00282087, 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 1 Dec 2014.