Clinical trial · Interventional
Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer
NCT00005820CI-TRIAL-00022983completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
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. 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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nitrocamptothecin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nitrocamptothecin
- description
- 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.
- interventionNames
- Drug: nitrocamptothecin
Primary outcomes (1)
- measure
- median time to disease and PSA progression
- timeFrame
- Up to 2 years
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (1)
- RESULTAmin A, Halabi S, Gelmann EP, Stadler W, Vogelzang N, Small E. 9-Nitrocamptothecin as second line chemotherapy for men with progressive, metastatic, hormone refractory prostate cancer: Results of the CALGB 99901. Urol Oncol. 2004 Sep-Oct;22(5):398-403. doi: 10.1016/j.urolonc.2004.05.002. PMID 15464920