Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Original Study ID : CDR0000446814

Secondary ID : CASE-CCF-7143

NCT ID : NCT00276549

Brief Title : Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Official Title : Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic 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.

Source : National Cancer Institute (NCI)

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.

Overall Status : Active, not recruiting

Start Date : October 2005

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Open Label

Enrollment : 36

Verification Date : February 2007

First Received Date : January 12, 2006

Trial 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

Gender : Male

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Cleveland Clinic Taussig Cancer Center

City : Cleveland

State : Ohio

Zip Code : 44195

Country : United States

OutComes

Primary OutComes

Interventions

Type : Drug

Name : docetaxel

Type : Drug

Name : gemcitabine hydrochloride

Clinical Trial Name - Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer