Trial Outcomes & Findings for Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer (NCT NCT00514540)
NCT ID: NCT00514540
Last Updated: 2020-09-01
Results Overview
TTP defined as time of registration on study till disease progression. Disease status evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.
Results posted on
2020-09-01
Participant Flow
All participants were enrolled between June 2006 and October 2010 at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
Of the 121 participants enrolled, seven were ineligible and excluded. Another participant was eligible but withdrew before treatment.
Participant milestones
| Measure |
Chemotherapy First-Line Chemo (CD) + Second-Line (EP)
First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m\^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines.
Second-Line (EP) Chemotherapy: Etoposide 120 mg/m\^2 daily for 3 days and Cisplatin 25 mg/m\^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
|
|---|---|
|
First-Line Chemo
STARTED
|
113
|
|
First-Line Chemo
COMPLETED
|
105
|
|
First-Line Chemo
NOT COMPLETED
|
8
|
|
Second-Line
STARTED
|
105
|
|
Second-Line
COMPLETED
|
74
|
|
Second-Line
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Chemotherapy First-Line Chemo (CD) + Second-Line (EP)
First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m\^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines.
Second-Line (EP) Chemotherapy: Etoposide 120 mg/m\^2 daily for 3 days and Cisplatin 25 mg/m\^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
|
|---|---|
|
First-Line Chemo
Withdrawal by Subject
|
1
|
|
First-Line Chemo
Protocol Violation
|
7
|
|
Second-Line
Physician/Patient Decision
|
31
|
Baseline Characteristics
Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
Baseline characteristics by cohort
| Measure |
First-Line CD + Second-Line EP
n=113 Participants
First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m\^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines.
Second-Line (EP) Chemotherapy: Etoposide 120 mg/m\^2 daily for 3 days and Cisplatin 25 mg/m\^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.TTP defined as time of registration on study till disease progression. Disease status evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1).
Outcome measures
| Measure |
First-Line: Carboplatin + Docetaxel
n=113 Participants
Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m\^2 IV over 60 minutes, Day 1 repeated every 3 weeks.
|
Second-Line: Etoposide + Cisplatin
n=74 Participants
Etoposide 120 mg/m\^2 daily for 3 days and Cisplatin 25 mg/m\^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
|
|---|---|---|
|
Median Time to Progression (TTP)
|
5.1 months
Interval 4.2 to 6.0
|
3.0 months
Interval 1.6 to 3.5
|
PRIMARY outcome
Timeframe: Evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1)Population: 74 of the 105 participants received second-line EP on study; the remainder withdrew from the study at their physician's or their own request. 2 participants died after course 1 of EP.
Response rate is the number of participants with response compared to total. Response defined as the absence of disease progression compared to the participant's baseline evaluation, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death.
Outcome measures
| Measure |
First-Line: Carboplatin + Docetaxel
n=74 Participants
Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m\^2 IV over 60 minutes, Day 1 repeated every 3 weeks.
|
Second-Line: Etoposide + Cisplatin
n=41 Participants
Etoposide 120 mg/m\^2 daily for 3 days and Cisplatin 25 mg/m\^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
|
|---|---|---|
|
Response Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin.
|
43 participants
|
24 participants
|
Adverse Events
First-Line: Carboplatin + Docetaxel
Serious events: 18 serious events
Other events: 112 other events
Deaths: 3 deaths
Second Line: Etoposide + Cisplatin
Serious events: 10 serious events
Other events: 58 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
First-Line: Carboplatin + Docetaxel
n=113 participants at risk
Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m2 IV over 60 minutes, Day 1 repeated every 3 weeks
|
Second Line: Etoposide + Cisplatin
n=74 participants at risk
Etoposide 120 mg/m2 daily for 3 days and Cisplatin 25 mg/m2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics), Repeated every 3 weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperbilirubin
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Vascular disorders
Disseminated Intravascular Coagulation
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.88%
1/113 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Cellulitis
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
2.7%
2/74 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Lung pneumonia
|
1.8%
2/113 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Upper airway infection
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Sepsis
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
2.7%
2/74 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
2.7%
2/74 • Number of events 3 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.88%
1/113 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
General disorders
Fatigue
|
1.8%
2/113 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Febrile Neutropenia
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
General disorders
Rigors/chills
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Vascular disorders
Thrombosis/embolism
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
2.7%
2/74 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Cardiac disorders
Hypotension
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Cardiac disorders
Vasovagal episode
|
0.00%
0/113 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Infection
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
2.7%
2/74 • Number of events 2 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/113 • Number of events 3 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Neutrophils/Granulocytes
|
0.88%
1/113 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
Other adverse events
| Measure |
First-Line: Carboplatin + Docetaxel
n=113 participants at risk
Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m2 IV over 60 minutes, Day 1 repeated every 3 weeks
|
Second Line: Etoposide + Cisplatin
n=74 participants at risk
Etoposide 120 mg/m2 daily for 3 days and Cisplatin 25 mg/m2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics), Repeated every 3 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils/Granulocytes
|
54.9%
62/113 • Number of events 129 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
29.7%
22/74 • Number of events 96 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.9%
27/113 • Number of events 45 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
23.0%
17/74 • Number of events 27 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
ALT elevated
|
13.3%
15/113 • Number of events 25 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
2.7%
2/74 • Number of events 3 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Anorexia
|
7.1%
8/113 • Number of events 15 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
5.4%
4/74 • Number of events 4 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
AST elevated
|
24.8%
28/113 • Number of events 42 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
13.5%
10/74 • Number of events 10 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
8.0%
9/113 • Number of events 15 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
4.1%
3/74 • Number of events 3 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.8%
10/113 • Number of events 36 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
20.3%
15/74 • Number of events 30 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
13/113 • Number of events 15 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
5.4%
4/74 • Number of events 4 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Creatinine
|
10.6%
12/113 • Number of events 17 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
17.6%
13/74 • Number of events 18 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.2%
42/113 • Number of events 68 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
28.4%
21/74 • Number of events 24 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Edema
|
15.9%
18/113 • Number of events 34 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
16.2%
12/74 • Number of events 12 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
General disorders
Fatigue (Asthenia, Lethargy, Malaise)
|
87.6%
99/113 • Number of events 359 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
59.5%
44/74 • Number of events 125 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
General disorders
Fever
|
9.7%
11/113 • Number of events 13 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
4.1%
3/74 • Number of events 3 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia
|
13.3%
15/113 • Number of events 16 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hemoglobin
|
67.3%
76/113 • Number of events 211 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
63.5%
47/74 • Number of events 139 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Infections and infestations
Infection with normal ANC
|
6.2%
7/113 • Number of events 8 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
4.1%
3/74 • Number of events 4 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction/Extravasation Changes
|
6.2%
7/113 • Number of events 9 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Leukocytes (Total WBC)
|
61.9%
70/113 • Number of events 204 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
36.5%
27/74 • Number of events 60 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.6%
38/113 • Number of events 67 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
47.3%
35/74 • Number of events 66 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
15.9%
18/113 • Number of events 20 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
1.4%
1/74 • Number of events 1 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Nausea
|
66.4%
75/113 • Number of events 216 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
45.9%
34/74 • Number of events 64 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Nervous system disorders
Neuropathy: Sensory
|
39.8%
45/113 • Number of events 79 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
21.6%
16/74 • Number of events 23 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
General disorders
Pain
|
15.0%
17/113 • Number of events 23 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
6.8%
5/74 • Number of events 6 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
7/113 • Number of events 11 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
6.8%
5/74 • Number of events 8 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Blood and lymphatic system disorders
Platelets
|
46.9%
53/113 • Number of events 124 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
56.8%
42/74 • Number of events 124 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.6%
21/113 • Number of events 30 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
12.2%
9/74 • Number of events 13 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.0%
26/113 • Number of events 45 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
33.8%
25/74 • Number of events 42 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Dysgeusia
|
5.3%
6/113 • Number of events 14 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
0.00%
0/74 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.4%
5/113 • Number of events 5 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
6.8%
5/74 • Number of events 5 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Vomitting
|
29.2%
33/113 • Number of events 97 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
17.6%
13/74 • Number of events 24 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Eye disorders
Watery Eye
|
23.0%
26/113 • Number of events 45 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
6.8%
5/74 • Number of events 9 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Diarrhea
|
49.6%
56/113 • Number of events 139 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
39.2%
29/74 • Number of events 31 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
|
Gastrointestinal disorders
Mucositis
|
15.0%
17/113 • Number of events 34 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
12.2%
9/74 • Number of events 15 • One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
|
Additional Information
Lisa Pruitt, Quality Assurance Specialist
University of Texas MD Anderson Cancer Center
Phone: 713-792-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place