Prostate CancerPhase 2NCT00084565
Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase 2 study testing estramustine phosphate sodium, paclitaxel and topotecan hydrochloride in people with Prostate Cancer, run by Fox Chase Cancer Center.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- estramustine phosphate sodium, paclitaxel and topotecan hydrochloride
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Nov 2004
- Phase
- Phase 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate gland
- Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases)
- Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease
- Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy
- Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA)
- PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease)
- No elevated serum acid phosphatase or PSA level as the only evidence of disease
- No carcinomatous meningitis or brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- White Blood Cell (WBC) ≥ 4,000/mm^3 OR
- Granulocyte count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine ≤ 2.0 mg/dL OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy
- No active angina pectoris
- No New York Heart Association class II-IV heart disease
- No myocardial infarction within the past 6 months
- No thrombosis within the past 3 months
Other
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active infection
- No other concurrent serious medical illness that would preclude study participation
- No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 4 weeks since prior flutamide
- At least 8 weeks since prior bicalutamide
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
Surgery
- See Disease Characteristics
Other
- Recovered from all prior therapy
- No prior cytotoxic therapy for prostate cancer
- No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration
About this study
Official title: Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
Secondary
- Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
- Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over 30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- estramustine phosphate sodium, paclitaxel, topotecan hydrochloride
- Keywords
- stage IV prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estramustine phosphate sodiumDrug
paclitaxelDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startNov 2003
- Primary completionNov 2004
- Study completionNov 2004
Why it stopped: Study was never activated at Fox Chase Cancer Center.
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 Fox Chase 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary R. Hudes, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084565
- Sponsor's protocol ID
- FCCC-03035
- Other IDs
- CDR0000365459
- Status last verified
- Jul 2013
- First submitted
- 10 Jun 2004
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT00084565
- Acronym / sponsor ID
- FCCC-03035
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never activated at Fox Chase Cancer Center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 11 Jun 2004 (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.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
Secondary
- Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
- Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression.
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over 30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| estramustine phosphate sodium | Drug | – |
| paclitaxel | Drug | – |
| topotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Gary R. Hudes, MD principal investigator
Fox Chase Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing estramustine phosphate sodium, paclitaxel and topotecan hydrochloride in people with Prostate Cancer, run by Fox Chase Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 10 Jul 2013.