Prostate CancerPhase 1/2NCT00038246
Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
A Phase 1/2 study testing Estramustine, Thalidomide and Paclitaxel (Taxol) in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Estramustine, Thalidomide and Paclitaxel (Taxol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Dec 2004
- Phase
- Phase 1/2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent.
- Histologic demonstration of adenocarcinoma of the prostate. Patients with variant histologies (ductal carcinoma, small cell carcinoma) are eligible only for the Phase I part of the trial, but are excluded from the Phase II. If no sample of the primary tumor was obtained, biopsy of a metastatic site is sufficient if the tissue stains positive for PSA. Some pathologic material must be available for review. Indicator need not be biopsy proven if the clinical presentation is characteristic.
- Androgen-Independent progression of prostate carcinoma, as shown by:
- 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.
- Patients must be off anti-androgens, such as flutamide (Eulexin), bicalutamide (Casodex) or nilutamide (Nilandron). They must have no evidence of response at least 4 weeks (6 weeks for bicalutamide) since anti-androgen withdrawal (or progression at any time since anti-androgen withdrawal).
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- Patients with nodal and/or visceral disease are eligible.
- Patients may have up to 2 prior chemotherapy regimens for prostate cancer, provided that more than 3 weeks have elapsed since the last treatment and patients have recovered from toxicity. Ketoconazole is considered chemotherapy. Prior Taxanes are allowed in both the Phase I and Phase II part of the trial. For the Phase II part of the study, patients must have progressed after >/= 1 and </= 2 prior chemotherapy regimens for prostate cancer (as neoadjuvant treatment or for metastatic disease).
- Up to one prior dose of Strontium-89 (Metastron) is allowed, if given more than 12 weeks prior to study entry. Patients may have had radiation therapy involving < 15% of the bone marrow (completed more than 3 weeks of initiation of the study).
- Previous treatment with PC-SPES, herbal / alternative medicines, anti-angiogenesis inhibitors, immunotherapy, or other non-androgen mediated pathways (such as epidermal growth factor receptor antagonists or farnesyl transferase inhibitors) is allowed, provided that there is unequivocal evidence of disease progression since completion of the therapy and more than 2 weeks have elapsed since last treatment.
- Patients must be at least 2 weeks from prior surgery.
- Adequate physiologic reserve as evidenced by:
- 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)].
- Absolute neutrophil count (ANC)>1500/mm^3; Platelets >100,000/mm^3; hemoglobin > 9.0 gm/dl.
Who cannot join
- Patients with variant histologies (ductal or small cell carcinoma) are excluded from the phase II part of the trial (are eligible for the phase I part).
- Patients with no prior chemotherapy for prostate cancer are excluded from the phase II part of the study.
- Patients with central nervous system (CNS) metastases or serious medical illnesses, active or uncontrolled infections, significant psychiatric disorders that preclude giving informed consent, patients with NCI grade > 2 peripheral neuropathy or patients with a history of another malignancy (except from superficial bladder cancer or basal cell carcinoma of the skin) within 5 years prior to study entry are excluded from the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (AI-PCa)
The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.
Read the detailed description
- Evaluate the maximum tolerated dose of oral daily thalidomide along with Paclitaxel (100 mg/m^2 as a 3-hour infusion weekly * 2, every 21 days) and oral estramustine phosphate (140 mg by mouth three times/day 5 days per week * 2 weeks, every 21 days) for patients with metastatic androgen-independent prostate carcinoma.
- Evaluate the efficacy of this regimen for patients with metastatic Androgen-Independent Prostate Cancer who failed up to two prior non-paclitaxel containing chemotherapy regimens, as measured by:
- 2A. The objective response rate and 'prostate-specific antigen (PSA) response rate' of the combination treatment in patients with AI-PCa progressing after chemotherapy.
- 2B. Secondary endpoints: calculate time to disease progression, effect on performance status, analgesic consumption, and survival.
- To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy.
- Conditions
- Prostate Cancer
- Being tested
- Estramustine, Thalidomide, Paclitaxel (Taxol)
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstramustineDrug
Also called Emcyt, Estramustine Phosphate
140 mg by mouth (po) three times a day on Days 1-5, 8-12
ThalidomideDrug
Also called Thalomid
200 mg by mouth every day once a week with dose escalation every week if no dose limiting toxicity.
Paclitaxel (Taxol)Drug
100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide, Taxol, Estramustine | Experimental | Thalidomide starting dose 200 mg by mouth every day once a week; Taxol 100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10; Estramustine 140 mg by mouth three times a day on Days 1-5, 8-12. Receives: Drug: Estramustine; Drug: Thalidomide; Drug: Paclitaxel (Taxol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) Thalidomide
MTD defined by Continuous reassessment method.
Measured: 21 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study startOct 2000
- Primary completionFeb 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Christopher J. Logothetis, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038246
- Sponsor's protocol ID
- ID00-087
- Status last verified
- Oct 2018
- First submitted
- 29 May 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (AI-PCa)
- ClinicalTrials.gov ID
- NCT00038246
- Acronym / sponsor ID
- ID00-087
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Oct 2000
- Primary completion
- Feb 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 30 May 2002 (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.
The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.
Detailed description
- Evaluate the maximum tolerated dose of oral daily thalidomide along with Paclitaxel (100 mg/m^2 as a 3-hour infusion weekly * 2, every 21 days) and oral estramustine phosphate (140 mg by mouth three times/day 5 days per week * 2 weeks, every 21 days) for patients with metastatic androgen-independent prostate carcinoma.
- Evaluate the efficacy of this regimen for patients with metastatic Androgen-Independent Prostate Cancer who failed up to two prior non-paclitaxel containing chemotherapy regimens, as measured by:
- 2A. The objective response rate and 'prostate-specific antigen (PSA) response rate' of the combination treatment in patients with AI-PCa progressing after chemotherapy.
- 2B. Secondary endpoints: calculate time to disease progression, effect on performance status, analgesic consumption, and survival.
- To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide, Taxol, Estramustine | Experimental | Drug: Estramustine, Drug: Thalidomide, Drug: Paclitaxel (Taxol)Thalidomide starting dose 200 mg by mouth every day once a week; Taxol 100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10; Estramustine 140 mg by mouth three times a day on Days 1-5, 8-12. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent.
- Histologic demonstration of adenocarcinoma of the prostate. Patients with variant histologies (ductal carcinoma, small cell carcinoma) are eligible only for the Phase I part of the trial, but are excluded from the Phase II. If no sample of the primary tumor was obtained, biopsy of a metastatic site is sufficient if the tissue stains positive for PSA. Some pathologic material must be available for review. Indicator need not be biopsy proven if the clinical presentation is characteristic.
- Androgen-Independent progression of prostate carcinoma, as shown by:
- Patients must be off anti-androgens, such as flutamide (Eulexin), bicalutamide (Casodex) or nilutamide (Nilandron). They must have no evidence of response at least 4 weeks (6 weeks for bicalutamide) since anti-androgen withdrawal (or progression at any time since anti-androgen withdrawal).
- Patients with nodal and/or visceral disease are eligible.
Key exclusion criteria (3 listed)
- Patients with variant histologies (ductal or small cell carcinoma) are excluded from the phase II part of the trial (are eligible for the phase I part).
- Patients with no prior chemotherapy for prostate cancer are excluded from the phase II part of the study.
- Patients with central nervous system (CNS) metastases or serious medical illnesses, active or uncontrolled infections, significant psychiatric disorders that preclude giving informed consent, patients with NCI grade > 2 peripheral neuropathy or patients with a history of another malignancy (except from superficial bladder cancer or basal cell carcinoma of the skin) within 5 years prior to study entry are excluded from the trial.
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 |
|---|---|---|
| EstramustineAlso: Emcyt, Estramustine Phosphate140 mg by mouth (po) three times a day on Days 1-5, 8-12 | Drug | Thalidomide, Taxol, Estramustine |
| ThalidomideAlso: Thalomid200 mg by mouth every day once a week with dose escalation every week if no dose limiting toxicity. | Drug | Thalidomide, Taxol, Estramustine |
| Paclitaxel (Taxol)100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10 | Drug | Thalidomide, Taxol, Estramustine |
Primary outcome
Maximum tolerated dose (MTD) Thalidomide
Time frame: 21 day cycles
MTD defined by Continuous reassessment method.
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 31 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Christopher J. Logothetis, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Estramustine, Thalidomide and Paclitaxel (Taxol) in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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 19 inclusion and 3 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 31 Oct 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose (MTD) Thalidomide (time frame: 21 day cycles). 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 31 Oct 2018.