Phase 2
Completed N=35
Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT00276549 ↗Enrolled (actual)
35
Serious AEs
20.0%
Results posted
Jun 2012
Primary outcomePrimary: Objective PSA Response Rate (Number of Patients With a PSA Response) — 17; 18 participants
Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine 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 gemcitabine together with docetaxel works in treating patients with metastatic prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective PSA Response Rate (Number of Patients With a PSA Response) |
17; 18 | — |
| PRIMARY Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST). |
3; 19 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Androgen-independent metastatic prostate cancer with evidence of clinical, radiographic, or biochemical progression in the setting of castrate levels of testosterone (< 50 mg/dL)
- No androgen-independent prostate cancer with a rising prostate-specific antigen (PSA) without clinical or radiographic evidence of metastases
- Clinical or radiographic evidence of metastatic disease with a rising PSA measured 2 times at ≥ 1 week interval allowed
- Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to study entry with evidence of either a rising PSA (from baseline) measured twice at least 2 weeks apart or radiographic evidence of disease progression
- Testicular androgen suppression (< 50 mg/dL) must be maintained with either luteinizing-hormone releasing-hormone (LHRH) therapy or bilateral orchiectomy
- No clinical evidence of CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times normal
- Creatinine < 2 mg/dL
- No history of severe uncontrolled congestive heart failure (CHF), ventricular dysrhythmias, or severe cardiovascular disease (American Heart Association class III or IV)
- Disease-free of prior malignancies for ≥ 5 years, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or low-grade, low-stage bladder cancer
- No active infection or parenteral antibiotics within 7 days of study entry
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No radiation therapy within 4 weeks prior to study entry
- No filgrastim (G-CSF) within 24 hours before or after study therapy
- No prior systemic chemotherapy for metastatic disease
- Neoadjuvant or adjuvant non-taxane chemotherapy more than 1 year prior to study entry allowed
- No concurrent local radiotherapy for control of pain or life-threatening situations
Data sourced from ClinicalTrials.gov (NCT00276549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.