Recurrent Uterine Corpus SarcomaPhase 2NCT00031629
Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
A Phase 2 study testing Docetaxel, Filgrastim and Gemcitabine Hydrochloride in people with Recurrent Uterine Corpus Sarcoma and Uterine Corpus Leiomyosarcoma, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma
- What is being tested?
- Docetaxel, Filgrastim and Gemcitabine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 2007
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed uterine leiomyosarcoma
- Recurrent or persistent disease that is refractory to curative therapy or established treatments
- Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
Show all 37Show fewer
- Lesions within a previously irradiated field allowed provided progression is documented or biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Ineligible for a high priority GOG protocol
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.1 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- No active infection requiring antibiotics
- No motor or sensory neuropathy greater than grade 1
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease
- At least 3 weeks since prior biologic or immunologic therapy for this disease
- See Disease Characteristics
- See Biologic therapy
- At least 3 weeks since prior chemotherapy and recovered
- No prior docetaxel or gemcitabine
- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens
- No prior chemotherapy for another malignancy that would preclude study
- At least 1 week since prior hormonal therapy for this disease
- Concurrent hormone replacement therapy allowed
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- See Disease Characteristics
- Recovered from prior recent surgery
- At least 3 weeks since other prior therapy for this disease
- No concurrent amifostine or other protective agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE:
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.
- Being tested
- Docetaxel, Filgrastim, Gemcitabine Hydrochloride, Pegfilgrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Given IV
FilgrastimBiological
Also called Filgrastim XM02, Filgrastim-sndz, G-CSF, Neupogen
Given SC
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Given IV
PegfilgrastimBiological
Also called Filgrastim SD-01, filgrastim-SD/01, HSP-130, Neulasta
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) | Experimental | Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Docetaxel; Biological: Filgrastim; Drug: Gemcitabine Hydrochloride; Biological: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and duration of objective response
Measured: Up to 5 years
Frequency of severity of observed adverse effects assessed using CTC version 2.0
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2005
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Uterine Corpus SarcomaStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Martee Hensley, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031629
- Sponsor's protocol ID
- GOG-0131G
- Other IDs
- NCI-2012-02456, CDR0000069206, GOG-0131G, GOG-0131G, U10CA027469
- Status last verified
- Dec 2016
- First submitted
- 8 Mar 2002
- Last updated
- 8 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
- ClinicalTrials.gov ID
- NCT00031629
- Acronym / sponsor ID
- GOG-0131G
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- First posted
- 27 Jan 2003 (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.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
Detailed description
PRIMARY OBJECTIVES:
- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE:
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) | Experimental | Drug: Docetaxel, Biological: Filgrastim, Drug: Gemcitabine Hydrochloride, Biological: PegfilgrastimPatients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Histologically confirmed uterine leiomyosarcoma
- At least 1 unidimensionally measurable lesion
- Ineligible for a high priority GOG protocol
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
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 |
|---|---|---|
| DocetaxelAlso: Docecad, RP56976, Taxotere, Taxotere Injection ConcentrateGiven IV | Drug | Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) |
| FilgrastimAlso: Filgrastim XM02, Filgrastim-sndz, G-CSF, NeupogenGiven SC | Biological | Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) |
| Gemcitabine HydrochlorideAlso: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011Given IV | Drug | Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) |
| PegfilgrastimAlso: Filgrastim SD-01, filgrastim-SD/01, HSP-130, NeulastaGiven IV | Biological | Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) |
Primary outcome
Frequency and duration of objective response
Time frame: Up to 5 years
Frequency of severity of observed adverse effects assessed using CTC version 2.0
Time frame: Up to 5 years
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
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 8 Dec 2016.
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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 Hensley principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Filgrastim and Gemcitabine Hydrochloride in people with Recurrent Uterine Corpus Sarcoma and Uterine Corpus Leiomyosarcoma, run by Gynecologic Oncology Group at 1 site 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 37 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Frequency and duration of objective response (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2016.