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Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer


- 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

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective PSA Response Rate (Number of Patients With a PSA Response)

Outcome Description:

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.

Outcome Time Frame:

every 4 weeks

Safety Issue:


Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

March 2008

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • Prostatic Neoplasms



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195