Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer
Brief 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.
Detailed description
OBJECTIVES: * Determine the objective response rate and toxicity in patients with androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride and docetaxel. OUTLINE: This is an open-label study. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 5 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Interventions
DRUGdocetaxel
docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
DRUGgemcitabine hydrochloride
IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective PSA Response Rate (Number of Patients With a PSA Response) | every 4 weeks | Decline from a baseline value by ≥ 50% or normalization of PSA (\< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized. |
| Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST). | at 4 weeks after treatment completion | Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from July 2004-October 2006 from medical clinic.
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine (Gemzar) and Docetaxel (Taxotere) Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Gemcitabine (Gemzar) and Docetaxel (Taxotere) |
|---|---|
| Age Continuous | 67 years |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 35 |
| serious Total, serious adverse events | 7 / 35 |
Outcome results
Primary
Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.
Time frame: at 4 weeks after treatment completion
Population: 25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST). | Partial Response | 3 participants |
| Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST). | Stable Disease | 19 participants |
Primary
Objective PSA Response Rate (Number of Patients With a PSA Response)
Decline from a baseline value by ≥ 50% or normalization of PSA (\< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.
Time frame: every 4 weeks
Population: All patients that received treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Objective PSA Response Rate (Number of Patients With a PSA Response) | Number of patients with a response ≥ 50% | 17 participants |
| Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Objective PSA Response Rate (Number of Patients With a PSA Response) | Number of patients with no response | 18 participants |