Trial Outcomes & Findings for Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma (NCT NCT02469116)
NCT ID: NCT02469116
Last Updated: 2016-08-19
Results Overview
TERMINATED
PHASE2
18 participants
Through 30 days after completion of treatment (approximately 22 weeks)
2016-08-19
Participant Flow
The study opened to participant enrollment on 01/12/2006 and closed to participant enrollment on 12/01/2009.
Participant milestones
| Measure |
Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)
* Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
* Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma
Baseline characteristics by cohort
| Measure |
Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)
n=18 Participants
* Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
* Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 30 days after completion of treatment (approximately 22 weeks)Outcome measures
| Measure |
Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)
n=18 Participants
* Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
* Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
|
|---|---|
|
Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3
Grade 3 neutropenia
|
4 participants
|
|
Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3
Grade 4 neutropenia
|
0 participants
|
SECONDARY outcome
Timeframe: Completion of treatment (approximately 18 weeks)* Progression is defined as one of the following: * Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 ≥ twice the upper limit of normal on two occasions at least one week apart * Patients with elevated CA-125 pretreatment which never normalizes must show evidence of CA-125 ≥ 2 times the nadir value OR \> 50% increase from the nadir on two occasions at least one week apart, * Patients with CA-125 in the normal range pretreatment must show evidence of CA-125 ≥ two times the upper limit of normal on two occasions at least one week apart. * Complete response is defined as a CA-125 value \<13 confirmed on two occasions at least 2 weeks apart. * Partial Response is defined as a reduction of at least 50% from the original elevated CA-125 value (original value must have been \> 50), confirmed on two occasions at least 2 weeks apart. * Stable Disease is defined as not meeting one of the above criteria.
Outcome measures
| Measure |
Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)
n=18 Participants
* Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
* Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
|
|---|---|
|
Efficacy of Regimen as Measured by CA-125 Response
Complete response
|
16 participants
|
|
Efficacy of Regimen as Measured by CA-125 Response
Partial response
|
1 participants
|
|
Efficacy of Regimen as Measured by CA-125 Response
Stable disease
|
0 participants
|
|
Efficacy of Regimen as Measured by CA-125 Response
Progressive disease
|
1 participants
|
SECONDARY outcome
Timeframe: Completion of follow-upPopulation: The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.
Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of follow-upPopulation: The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.
Overall Survival is the observed length of life from entry into the study to death or the date of last contact
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of follow-upPopulation: The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.
-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of follow-upPopulation: The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.
* The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section * Answers range from "Not at all" to "Very Much" with 0 = not at all and 4 = very much
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after completion of treatment (approximately 22 weeks)Outcome measures
| Measure |
Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)
n=18 Participants
* Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
* Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
|
|---|---|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Low white blood cell count
|
25 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Low absolute neutrophil count
|
21 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Low platelet count
|
47 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Low hemoglobin
|
78 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Allergy/immunology
|
3 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Cardiovascular
|
4 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Coagulation
|
1 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Constitutional symptoms
|
42 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Dermatology
|
64 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Endocrine
|
56 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Gastrointestinal
|
43 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Genitourinary/renal
|
1 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Hemorrhage
|
2 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Infection/febrile neutropenia
|
9 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Lymphatics
|
2 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Metabolic/laboratory
|
74 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Musculoskeletal
|
6 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Neurologic
|
30 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Ocular/visual
|
2 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Pain
|
27 events
|
|
Adverse Events as Measured by Number of Events Experienced by All Participants
Pulmonary
|
2 events
|
Adverse Events
Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David G. Mutch, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place