Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Brief summary
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
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.
Interventions
DRUGnitrocamptothecin
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median time to disease and PSA progression | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | Up to 2 years |
Countries
United States
Outcome results
None listed