Clinical trial · Interventional

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate

NCT00028769CI-TRIAL-00011370completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (8)

Intervention	Type	Mapped drug	Match
bicalutamide	Drug	Bicalutamide	ALIAS
estramustine	Drug	Estramustine	ALIAS
etoposide	Drug	Etoposide	ALIAS
flutamide	Drug	Flutamide	ALIAS
goserelin	Drug	Goserelin	ALIAS
leuprolide	Drug	Leuprolide	ALIAS
nilutamide	Drug	Nilutamide	ALIAS
paclitaxel	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Hormone therapy, estramustine, etoposide and paclitaxel
description
Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel
interventionNames
1. Drug: bicalutamide
2. Drug: estramustine
3. Drug: etoposide
4. Drug: flutamide
5. Drug: goserelin
6. Drug: leuprolide
7. Drug: nilutamide
8. Drug: paclitaxel

Primary outcomes (2)

measure
Progression-free Survival
timeFrame
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)
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.

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 1, 2001
Primary completion: Jun 1, 2010
Completion: Jul 1, 2011
First posted: Jan 27, 2003
Last update posted: Jul 16, 2013
Results first posted: Jul 16, 2013
Enrollment: 41 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Data updated 22 days agoSource updated Jul 16, 2013source: clinicaltrials

Locations

Locations by country (91)

Country	Sites	Recruiting
United States	91	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.