Phase 2
Completed N=41
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT00028769 ↗Enrolled (actual)
41
Serious AEs
17.1%
Results posted
Jul 2013
Primary outcomePrimary: Progression-free Survival — 13 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
13 | — |
| PRIMARY Overall Survival (OS) |
38 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
1; 1; 1; 1; 1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00028769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.