Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT00820898) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
United States24 participantsStarted 2009-02
Plain-language 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 from dividing.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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 eligi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
2
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up