Endometrial AdenocarcinomaPhase 2NCT00820898
Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
A Phase 2 study testing Gemcitabine Hydrochloride in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 20 sites in United States.
Trial summary
This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma
- What is being tested?
- Gemcitabine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 20 sitesUnited States
- Study dates
- Feb 2009to Jan 2011
- 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
- Histologically confirmed endometrial adenocarcinoma
- Recurrent or persistent disease
- Refractory to curative therapy or established treatments
- The following epithelial cell types are eligible:
- Endometrioid adenocarcinoma
- Serous adenocarcinoma
Show all 47Show fewer
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Adenocarcinoma not otherwise specified
- Mucinous adenocarcinoma
- Squamous cell carcinoma
- Transitional cell carcinoma
- Mesonephric carcinoma
- Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR as ≥ 10 mm by spiral CT scan
- Must have ≥ 1 target lesion
- Tumors within a previously irradiated field are designated as target lesions provided there is documented disease progression or biopsy confirmed persistent disease ≥ 90 days after completion of radiotherapy
- Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
- Initial treatment may have included non-cytotoxic agents or high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
- No more than one prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
- One additional non-cytotoxic regimen for management of recurrent or persistent disease is allowed
- Not eligible for a higher priority GOG protocol, if one exists (i.e., any active Phase III GOG protocol for the same patient population)
- GOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No neuropathy (sensory and motor) > grade 1, according to NCI CTCAE v3.0
- No active infection requiring antibiotics (except an uncomplicated urinary tract infection)
- No other invasive malignancies within the past 5 years except non-melanoma skin cancer
- No prior cancer treatment that contraindicates study therapy
- Recovered from prior surgery, radiotherapy, or chemotherapy
- At least 1 week since prior hormonal therapy for endometrial cancer
- At least 3 weeks since prior biological therapy, immunotherapy, or other therapy for endometrial cancer
- At least 4 weeks since prior radiotherapy
- More than 3 years since prior radiotherapy for localized breast cancer, head and neck cancer, or skin cancer and
- No recurrent or persistent breast cancer, head and neck cancer, or skin cancer
- More than 3 years since prior adjuvant chemotherapy for localized breast cancer
- No recurrent or metastatic breast cancer
- No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
- No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
- No prior gemcitabine hydrochloride
Who cannot join
None listed.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Carolinas Medical Center
Charlotte, North Carolina, 28203
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
MetroHealth Medical Center
Cleveland, Ohio, 44109
Riverside Methodist Hospital
Columbus, Ohio, 43214
Zale Lipshy University Hospital
Dallas, Texas, 75235
Decatur Memorial Hospital
Decatur, Illinois, 62526
Hartford Hospital
Hartford, Connecticut, 06102
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
Women and Infants Hospital
Providence, Rhode Island, 02905
Memorial Medical Center
Springfield, Illinois, 62781-0001
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146
About this study
Official title: A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols.
II. To determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Gemcitabine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Measured: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
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.
- Other trials for Endometrial AdenocarcinomaStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Tait, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820898
- Sponsor's protocol ID
- GOG-0129Q
- Other IDs
- NCI-2009-01175, GOG-0129Q, CDR0000631591, GOG-0129Q, GOG-0129Q, U10CA027469
- Status last verified
- May 2015
- First submitted
- 9 Jan 2009
- Last updated
- 29 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00820898
- Acronym / sponsor ID
- GOG-0129Q
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Recurrent Uterine Corpus Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Posted 5 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols.
II. To determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Gemcitabine HydrochloridePatients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days 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 (47 listed)
- Histologically confirmed endometrial adenocarcinoma
- The following epithelial cell types are eligible:
- Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR as ≥ 10 mm by spiral CT scan
- Must have ≥ 1 target lesion
- Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
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 |
|---|---|---|
| Gemcitabine HydrochlorideAlso: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011Given IV | Drug | Arm I |
Primary outcome
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Tait principal investigator
Gynecologic Oncology Group
20 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 Hydrochloride in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 20 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 47 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 29 Dec 2017. 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 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 5 Dec 2017). 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?
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 (time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for 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 29 Dec 2017.