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

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.

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