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Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
gemcitabine hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine and Docetaxel i

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2006
Last Updated
January 24, 2013
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine and Docetaxel i
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective PSA Response Rate (Number of Patients With a PSA Response)
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.
Time Frame
every 4 weeks
Title
Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Dreicer, MD, FACP
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

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