Trial Outcomes & Findings for Taxol Carboplatin and Erythropoetin (NCT NCT00158379)

Results Overview

Time to progression

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

every 3 months for up to 3 years

Results posted on

2017-02-06

recruitment period: July 2003 - December 2004

Participant milestones
Measure	Paclitaxel Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Overall Study STARTED	105
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Taxol Carboplatin and Erythropoetin

Baseline characteristics by cohort
Measure	Paclitaxel n=105 Participants Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Age, Continuous	60.4 years n=5 Participants
Gender Female	105 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment Germany	105 participants n=5 Participants

Timeframe: every 3 months for up to 3 years

Time to progression

Outcome measures
Measure	Paclitaxel n=105 Participants Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%	28.8 months Interval 25.4 to 40.0

Timeframe: after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years

defined as hematological and non-hematological adverse events of grade \>= grade 1

Outcome measures
Measure	Paclitaxel n=105 Participants Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Toxicity	105 participants

Serious events: 13 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events
Measure	Paclitaxel n=105 participants at risk Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Gastrointestinal disorders Nausea	1.9% 2/105 • Number of events 3
General disorders Death	0.95% 1/105 • Number of events 1
General disorders Disease progression	0.95% 1/105 • Number of events 1
Vascular disorders Suspected thrombosis	1.9% 2/105 • Number of events 2
Gastrointestinal disorders Ileus	2.9% 3/105 • Number of events 3
General disorders deterioration of general condition	4.8% 5/105 • Number of events 5
Vascular disorders embolism	1.9% 2/105 • Number of events 4

Other adverse events
Measure	Paclitaxel n=105 participants at risk Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Blood and lymphatic system disorders Anemia	100.0% 105/105 • Number of events 178

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