CompletedPhase 2

Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

United States60 participantsStarted 2001-09

Plain-language summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor

Who can participate

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 carcinoma * Recurrent or persistent (refractory to curative therapy or established treatment) * No sarcomas * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI * At least 10 mm by spiral CT scan * At least 1 target lesion outside the area of prior radiotherapy * Received 1 prior chemotherapy regimen for endometrial carcinoma * Initial treatment may include high-dose therapy, consolidation, or extended therapy * No more than 1 additional cytotoxic regimen for recurrent or persistent disease * No non-cytotoxic chemotherapy for recurrent or persistent disease * Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population) * No documented brain metastases since diagnosis of cancer * Patients with stable CNS deficits allowed provided there are no brain metastases, as confirmed by CT scan or MRI * Performance status - GOG 0-2 if patient received 1 prior regimen * Performance status - GOG 0-1 if patient received 2 prior regimens * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 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 * Creatinine clearance greater than 60 mL/min * Not pr…

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

Proportion of patients alive and progression-free

Timeframe: 6 months

Frequency of adverse events assessed by CTC

Timeframe: Up to 6 years

Trial details

NCT IDNCT00025467

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2007-07

View on ClinicalTrials.gov More Endometrial Adenoacanthoma trials

Who can participate

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.