Clinical trial · Interventional
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
NCT00258284CI-TRIAL-00013955completedPhase 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, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate 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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel & Capecitabine
- description
- Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
- interventionNames
- Drug: capecitabine
- Drug: docetaxel
Primary outcomes (1)
- measure
- Response rate by RECIST criteria after every 2 courses
- timeFrame
- at cycle 2 and every other cycle thereafter
Secondary outcomes (5)
- measure
- Toxicity at 30 days after last treatment
- timeFrame
- Every week during treatment cycles
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic disease
* Androgen-independent disease
* Progressive disease, as documented by ≥ 1 of the following criteria:
* Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal
* Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart
* Measurable disease progression
* Nonmeasurable disease progression, defined as the following:
* PSA ≥ 5 ng/mL
* New areas of bone metastases on bone scan
* Serum testosterone ≤ 0.5 ng/mL (castrate level)
* Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients
PATIENT CHARACTERISTICS:
Performance status
* Zubrod 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/ mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
* Transaminases meeting 1 of the following criteria:
* AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal
* AP ≤ 4 times ULN if AST and/or ALT normal
Renal
* Creatinine clearance ≥ 50 mL/min OR
* Creatinine ≤ 2 mg/dL
Cardiovascular
* No congestive heart failure
* No second- or third-degree heart block
* No myocardial infarction within the past 3 months
Other
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy for metastatic disease
Endocrine therapy
* See Disease Characteristics
* More than 4 weeks since prior flutamide
* More than 6 weeks since prior bicalutamide or nilutamide
Radiotherapy
* At least 4 weeks since prior radiotherapy
Other
* At least 28 days since prior investigational drugs for prostate cancer
* No other concurrent anti-cancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.