Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CCF-7143 | Other Identifier | Cleveland Clinic IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine and Docetaxel i | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 4 weeks |
| 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. | at 4 weeks after treatment completion |
Not provided
Not provided
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)
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:
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
No concurrent local radiotherapy for control of pain or life-threatening situations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Dreicer, MD, FACP | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
Not provided
Patients were recruited from July 2004-October 2006 from medical clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients that received treatment. | Posted | Number | participants | every 4 weeks |
|
Patients were followed for adverse events while on treatment and on study over a two year time frame.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine (Gemzar) and Docetaxel (Taxotere) | Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Dreicer | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | 216-445-4623 | dreicer@ccf.org |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| gemcitabine hydrochloride | 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. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | 25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable. | Posted | Number | participants | at 4 weeks after treatment completion |
|
|
|
| 7 |
| 35 |
| 35 |
| 35 |
| Neutropenia/fever | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chills/Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness/lightheadedness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated AST (aspartate aminotransferase); ALT (alanine aminotransferase) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever without Neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache/Migraine | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot Flashes/Flushes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Increased Alkaline Phosphatase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis (oral) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia/Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal Congestion/Drainage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Other Gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Taste changes | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tearing | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight Loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |