Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma
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|ClinicalTrials.gov Identifier: NCT02469116|
Recruitment Status : Terminated (Sponsor withdrew financial support)
First Posted : June 11, 2015
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
In this study the investigators will be using an AUC of 6 based on creatinine clearance using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.
Given that myelosuppression was significant using the docetaxel dose of 75 mg/m*2 in the SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted. The expectation would be that patients will be able to receive their cycles in a more timely fashion, with less delays, thereby allowing for improved outcomes and decreased hospitalizations due to myelosuppression.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Docetaxel Drug: Carboplatin Drug: Pegylated G-CSF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in the Front-line Treatment of Patients With Advanced Stage Ovarian Carcinoma|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||March 2010|
Experimental: Arm 1: (docetaxel, carboplatin, pegylated G-CSF)
Drug: Pegylated G-CSF
- Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3 [ Time Frame: Through 30 days after completion of treatment (approximately 22 weeks) ]
- Efficacy of Regimen as Measured by CA-125 Response [ Time Frame: 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.
- Time to Progression (TTP) [ Time Frame: Completion of follow-up ]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.
- Overall Survival (OS) [ Time Frame: Completion of follow-up ]Overall Survival is the observed length of life from entry into the study to death or the date of last contact
- Progression-free Survival (PFS) [ Time Frame: Completion of follow-up ]-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
- Quality of Life (QoL) as Measured by FACT-O Assessment Tool [ Time Frame: Completion of follow-up ]
- 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
- Adverse Events as Measured by Number of Events Experienced by All Participants [ Time Frame: 30 days after completion of treatment (approximately 22 weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469116
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||David G Mutch, M.D.||Washington University School of Medicine|