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Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Carboplatin
Pegylated G-CSF
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed newly diagnosed Stage III/IV epithelial ovarian or primary peritoneal carcinoma at time of initial diagnosis
  • Treatment must start within 8 weeks of surgery
  • Subjects may be measurable per RECIST criteria or evaluable for disease response by CA125. Evaluable CA 125 levels are defined as an elevated CA125 pre operatively which either remains elevated post-operatively or normalizes after surgery
  • No prior chemotherapy or radiation therapy
  • Age ≥ 18
  • Performance Status must be ≤ 2 (ECOG)
  • Peripheral neuropathy: must be ≤ grade 1

  • Hematologic (minimal values)

    • Absolute neutrophil count ≥ 1,500/mm3
    • Hemoglobin ≥ 8.0 g/dl
    • Platelet count ≥ 100,000/mm3

  • Hepatic

    *Total Bilirubin ≤ ULN

  • AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.

    • If alkaline phosphatase is ≤ ULN and AST or ALT is >5x ULN then the patient is not eligible
    • If alkaline phosphatase is >1x but ≤2.5 x the ULN and the AST or ALT is >1.5x the ULN then the patient is not eligible
    • If alkaline phosphatase is >2.5x but ≤5x the ULN and the AST or ALT is >1x the ULN then the patient is not eligible
    • If alkaline phosphatase is >5x the ULN then the patient is not eligible
  • Renal: Creatinine (serum) less than or equal to 1.5 ULN, CTC grade 1.
  • Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

PT/PTT ≤ 1.5 x's ULN

Exclusion Criteria:

  • Patients with a history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
  • Women who are pregnant or breast-feeding.
  • Patients who have signs of infection or who have not recovered from the effects of recent surgery
  • Patients with a performance status of 3 or 4
  • Patients with a second malignancy within past 5 years other than non-melanoma skin carcinoma.
  • Patients who have received prior myelosuppressive chemotherapy or XRT.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: (docetaxel, carboplatin, pegylated G-CSF)

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3

Secondary Outcome Measures

Efficacy of Regimen as Measured by CA-125 Response
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)
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)
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)
-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
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

Full Information

First Posted
June 1, 2015
Last Updated
July 11, 2016
Sponsor
Washington University School of Medicine
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02469116
Brief Title
Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew financial support
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: (docetaxel, carboplatin, pegylated G-CSF)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docefrez®, Taxotere®
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin, CBDCA
Intervention Type
Drug
Intervention Name(s)
Pegylated G-CSF
Other Intervention Name(s)
Neulasta®), Pegfilgrastim
Primary Outcome Measure Information:
Title
Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3
Time Frame
Through 30 days after completion of treatment (approximately 22 weeks)
Secondary Outcome Measure Information:
Title
Efficacy of Regimen as Measured by CA-125 Response
Description
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 Frame
Completion of treatment (approximately 18 weeks)
Title
Time to Progression (TTP)
Description
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.
Time Frame
Completion of follow-up
Title
Overall Survival (OS)
Description
Overall Survival is the observed length of life from entry into the study to death or the date of last contact
Time Frame
Completion of follow-up
Title
Progression-free Survival (PFS)
Description
-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time Frame
Completion of follow-up
Title
Quality of Life (QoL) as Measured by FACT-O Assessment Tool
Description
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
Time Frame
Completion of follow-up
Other Pre-specified Outcome Measures:
Title
Adverse Events as Measured by Number of Events Experienced by All Participants
Time Frame
30 days after completion of treatment (approximately 22 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed newly diagnosed Stage III/IV epithelial ovarian or primary peritoneal carcinoma at time of initial diagnosis Treatment must start within 8 weeks of surgery Subjects may be measurable per RECIST criteria or evaluable for disease response by CA125. Evaluable CA 125 levels are defined as an elevated CA125 pre operatively which either remains elevated post-operatively or normalizes after surgery No prior chemotherapy or radiation therapy Age ≥ 18 Performance Status must be ≤ 2 (ECOG) Peripheral neuropathy: must be ≤ grade 1 Hematologic (minimal values) Absolute neutrophil count ≥ 1,500/mm3 Hemoglobin ≥ 8.0 g/dl Platelet count ≥ 100,000/mm3 Hepatic *Total Bilirubin ≤ ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. If alkaline phosphatase is ≤ ULN and AST or ALT is >5x ULN then the patient is not eligible If alkaline phosphatase is >1x but ≤2.5 x the ULN and the AST or ALT is >1.5x the ULN then the patient is not eligible If alkaline phosphatase is >2.5x but ≤5x the ULN and the AST or ALT is >1x the ULN then the patient is not eligible If alkaline phosphatase is >5x the ULN then the patient is not eligible Renal: Creatinine (serum) less than or equal to 1.5 ULN, CTC grade 1. Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. PT/PTT ≤ 1.5 x's ULN Exclusion Criteria: Patients with a history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80. Women who are pregnant or breast-feeding. Patients who have signs of infection or who have not recovered from the effects of recent surgery Patients with a performance status of 3 or 4 Patients with a second malignancy within past 5 years other than non-melanoma skin carcinoma. Patients who have received prior myelosuppressive chemotherapy or XRT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Mutch, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma

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