Trial Outcomes & Findings for Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer (NCT NCT00276549)
NCT ID: NCT00276549
Last Updated: 2013-01-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
every 4 weeks
Results posted on
2013-01-31
Participant Flow
Patients were recruited from July 2004-October 2006 from medical clinic.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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35
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine (Gemzar) and Docetaxel (Taxotere)
n=35 Participants
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.
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|---|---|
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Age Continuous
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67 years
n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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35 Participants
n=5 Participants
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Region of Enrollment
United States
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35 participants
n=5 Participants
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PRIMARY outcome
Timeframe: every 4 weeksPopulation: All patients that received treatment.
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.
Outcome measures
| Measure |
Gemcitabine (Gemzar) and Docetaxel (Taxotere)
n=35 Participants
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.
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|---|---|
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Objective PSA Response Rate (Number of Patients With a PSA Response)
Number of patients with a response ≥ 50%
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17 participants
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Objective PSA Response Rate (Number of Patients With a PSA Response)
Number of patients with no response
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18 participants
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PRIMARY outcome
Timeframe: at 4 weeks after treatment completionPopulation: 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.
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.
Outcome measures
| Measure |
Gemcitabine (Gemzar) and Docetaxel (Taxotere)
n=22 Participants
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.
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|---|---|
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Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
Partial Response
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3 participants
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Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
Stable Disease
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19 participants
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Adverse Events
Gemcitabine (Gemzar) and Docetaxel (Taxotere)
Serious events: 7 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine (Gemzar) and Docetaxel (Taxotere)
n=35 participants at risk
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.
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|---|---|
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Blood and lymphatic system disorders
Neutropenia
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17.1%
6/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Neutropenia/fever
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2.9%
1/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Thrombocytopenia
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2.9%
1/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Other adverse events
| Measure |
Gemcitabine (Gemzar) and Docetaxel (Taxotere)
n=35 participants at risk
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.
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|---|---|
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Skin and subcutaneous tissue disorders
Alopecia
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80.0%
28/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Anemia
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45.7%
16/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Metabolism and nutrition disorders
Anorexia
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37.1%
13/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Musculoskeletal and connective tissue disorders
Back Pain
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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General disorders
Chills/Rigors
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20.0%
7/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Gastrointestinal disorders
Constipation
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28.6%
10/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Gastrointestinal disorders
Diarrhea
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28.6%
10/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Nervous system disorders
Dizziness/lightheadedness
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11.4%
4/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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31.4%
11/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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General disorders
Edema
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45.7%
16/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Hepatobiliary disorders
Elevated AST (aspartate aminotransferase); ALT (alanine aminotransferase)
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20.0%
7/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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General disorders
Fatigue
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80.0%
28/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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General disorders
Fever without Neutropenia
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40.0%
14/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Skin and subcutaneous tissue disorders
Flushing
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Nervous system disorders
Headache/Migraine
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Endocrine disorders
Hot Flashes/Flushes
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Hepatobiliary disorders
Increased Alkaline Phosphatase
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Leukopenia
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31.4%
11/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Lymphopenia
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8.6%
3/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Gastrointestinal disorders
Mucositis (oral)
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17.1%
6/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Musculoskeletal and connective tissue disorders
Muscle Weakness
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
|
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Musculoskeletal and connective tissue disorders
Myalgia/Arthralgia
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11.4%
4/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Skin and subcutaneous tissue disorders
Nail Changes
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17.1%
6/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Respiratory, thoracic and mediastinal disorders
Nasal Congestion/Drainage
|
5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Gastrointestinal disorders
Nausea/vomiting
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57.1%
20/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Nervous system disorders
Neuropathy
|
25.7%
9/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Neutropenia
|
40.0%
14/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Gastrointestinal disorders
Other Gastrointestinal
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17.1%
6/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Skin and subcutaneous tissue disorders
Rash/desquamation
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22.9%
8/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Infections and infestations
Rhinitis
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8.6%
3/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Nervous system disorders
Taste changes
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42.9%
15/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Eye disorders
Tearing
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5.7%
2/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Blood and lymphatic system disorders
Thrombocytopenia
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11.4%
4/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Investigations
Weight Loss
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8.6%
3/35 • Patients were followed for adverse events while on treatment and on study over a two year time frame.
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Additional Information
Dr. Robert Dreicer
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-445-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place