Clinical trial · Interventional
S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)
Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
NCT00058448CI-TRIAL-00033491terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to poor patient recruitment.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer.
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 |
|---|---|---|---|
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment
- timeFrame
- up to 24 weeks during treatment
Secondary outcomes (1)
- measure
- Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks
- timeFrame
- up to 24 weeks during treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed epidermoid carcinoma of the penis * Distant metastases (M1) OR * Pathologically confirmed regional nodal metastases (N1-3) * Measurable disease * Soft tissue disease irradiated within the past 2 months is not considered measurable disease PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * White blood cell (WBC) count at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Aspartate aminotransferase (SGOT) no greater than 2.5 times ULN * If SGOT is greater than ULN, alkaline phosphatase must be no greater than 2.5 times ULN * Alkaline phosphatase no greater than 4 times ULN * If alkaline phosphatase is greater than ULN, SGOT must be no greater than 1.5 times ULN Renal * Not specified Other * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission * No grade 2 or greater peripheral neuropathy * No hypersensitivity to drugs formulated with polysorbate 80 (e.g., recombinant interferon alfa-2a, multivitamin infusion, etoposide, infliximab, or NovoSeven factor) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for penile cancer Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.