Primary outcomeMedian· 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)
Progression-free Survival
| Group | Value (months) |
|---|---|
| CAD + Chemo | 13 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataS0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
NCTNCT00028769 (opens ClinicalTrials.gov in a new tab)Other idCDR0000069132Other idS0032Other idU10CA032102
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 41 participants (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- Dec 2001
- Primary completion
- Jun 2010
- Completion
- Jul 2011
- First posted
- 27 Jan 2003 (estimated)
- Last update posted
- 16 Jul 2013 (estimated)
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200220042006200820102012
- Ph 2
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
NCT00028769Dec 2001 to Jul 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.
Interventions
- bicalutamideDrug
- estramustineDrug
- etoposideDrug
- flutamideDrug
- goserelinDrug
- leuprolideDrug
- nilutamideDrug
- paclitaxelDrug
Arms1
Experimental
Hormone therapy, estramustine, etoposide and paclitaxel
Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel
Primary outcomes2
Outcomes the sponsor listed as primary.
Progression-free Survival
Time frame · 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)
Registry description
Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.
Overall Survival (OS)
Time frame · 0-5 years
Registry description
Overall survival is defined from the date of registration to date of death from any cause
Secondary outcomes(1)
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Time frame · up to 5 years after registration
Registry description
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMedian· 0-5 years
Overall Survival (OS)
| Group | Value (months) |
|---|---|
| CAD + Chemo | 38 |
Secondary and other outcome results(1)
Secondary outcomeNumber· up to 5 years after registration
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
| Group | Value (Participants) |
|---|---|
| CAD + Chemo | 1 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CAD + ChemoPatients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle) | – | 6 / 35 | 35 / 35 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
* Clinical stage D2 disease as evidenced by one of the following:
* Visceral disease (liver, lung, or other viscera)
* Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull) and appendicular (claviculae, humeri, or femora) skeleton
* No prior or concurrent (treated or untreated) brain metastases
* Patients with clinical evidence of brain metastasis must have a negative brain CT or MRI
* No evidence of untreated spinal cord compression
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active hypercoagulability
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No transient ischemic attacks, stroke, or myocardial infarction within the past 6 months
* No active coronary artery disease requiring antianginal therapy
* No active thrombophlebitis
Pulmonary:
* No history of pulmonary embolus
Other:
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy and recovered
* No concurrent biologic therapy
Chemotherapy:
* No prior cytotoxic chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist and antiandrogen therapy) allowed if administered for a duration of less than 30 days
* Prior neoadjuvant hormonal therapy allowed
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* At least 4 weeks since prior surgery and recovered
Other:
* No concurrent bisphosphonates
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