Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00276549

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-03-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine and Docetaxel i

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

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.

gemcitabine hydrochloride

Intervention Type: DRUG

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.

Interventions

docetaxel

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

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dreicer, MD, FACP

Role: STUDY_CHAIR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-7143

Identifier Type: OTHER

Identifier Source: secondary_id

CCF7143

Identifier Type: -

Identifier Source: org_study_id