CompletedPhase 1/2

Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma

United States40 participantsStarted 2000-10

Plain-language summary

The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.

Who can participate

Sex

MALE

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

. Serum testosterone level of \< 50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone (LHRH agonists) should continue, and
. Either symptomatic progression, or, if patient is asymptomatic, then a rising serum PSA in two occasions at least 1 week apart, with a minimum pre-treatment serum PSA of 5.
. Life expectancy of at least 12 weeks
. Zubrod performance status of \< 2.
. Age \> 18 years old.
. No clinical history of heart disease and a normal elect electrocardiogram (EKG or ECG), OR an ejection fraction of at least 45% (by echocardiogram (ECHO), Multiple Gated Acquisition (MUGA) or ventriculography).
. serum glutamic pyruvic transaminase (SGOT/SGPT) and conjugated bilirubin less than twice the upper limit of normal.
. Serum creatinine \< 2.0 mg/dl (or, if creatinine \> 2 mg/dl, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockcroft formula: CLcr= \[(140-age) \* weight (kg)\] / \[72 \* serum creatinine (mg/dl)\].

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

Maximum tolerated dose (MTD) Thalidomide

Timeframe: 21 day cycles

Trial details

NCT IDNCT00038246

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-02

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Sex

MALE

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

. Serum testosterone level of \< 50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone (LHRH agonists) should continue, and
. Either symptomatic progression, or, if patient is asymptomatic, then a rising serum PSA in two occasions at least 1 week apart, with a minimum pre-treatment serum PSA of 5.
. Life expectancy of at least 12 weeks
. Zubrod performance status of \< 2.
. Age \> 18 years old.
. No clinical history of heart disease and a normal elect electrocardiogram (EKG or ECG), OR an ejection fraction of at least 45% (by echocardiogram (ECHO), Multiple Gated Acquisition (MUGA) or ventriculography).
. serum glutamic pyruvic transaminase (SGOT/SGPT) and conjugated bilirubin less than twice the upper limit of normal.
. Serum creatinine \< 2.0 mg/dl (or, if creatinine \> 2 mg/dl, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockcroft formula: CLcr= \[(140-age) \* weight (kg)\] / \[72 \* serum creatinine (mg/dl)\].