Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy.

Detailed Description
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OBJECTIVES: Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic, hormone refractory prostate cancer. Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen. Determine the safety, tolerance, and toxicity of this treatment regimen in these patients. OUTLINE: Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study over 2 years.

Official Title
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A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: nitrocamptothecin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with clinically progressive stage IVA or IVB disease after at least primary androgen ablation with either orchiectomy or LHRH agonist and only one cytotoxic chemotherapy regimen Measurable disease with a maximum of 10 measurable lesions OR nonmeasurable disease Serum testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) No disseminated intravascular coagulation Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Fertile patients must use effective contraception No currently active second malignancy other than nonmelanoma skin cancers No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 6 weeks since prior suramin At least 4 weeks since other prior chemotherapy No prior therapy with camptothecin or any of its analogues Endocrine therapy: Prior second line hormonal therapy allowed At least 4 weeks since prior hormonal therapy Concurrent treatment with LHRH agonists allowed and required for patients without orchiectomy No concurrent hormonal therapy except for nondisease related conditions Concurrent corticosteroids allowed if on stable dose for at least 6 weeks before study No concurrent dexamethasone as an antiemetic Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No palliative radiotherapy At least 8 weeks since prior strontium 89 or samarium 153 Surgery: At least 3 weeks since major surgery and recovered
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitrocamptothecin<br>Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration. | Drug: nitrocamptothecin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median time to disease and PSA progression |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer