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Sponsored by: |
Case Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00276549 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | October 2005 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for metastatic disease
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Robert Dreicer, MD, FACP | The Cleveland Clinic |
Study ID Numbers: | CDR0000446814, CASE-CCF-7143 |
Study First Received: | January 12, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00276549 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Gemcitabine Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |