Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Docetaxel Drug: Carboplatin Drug: Pegylated G-CSF Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: 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
Drug: Docetaxel
Other Names:
  • Docefrez®
  • Taxotere®

Drug: Carboplatin
Other Names:
  • Paraplatin
  • CBDCA

Drug: Pegylated G-CSF
Other Names:
  • Neulasta®)
  • Pegfilgrastim




Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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


Other Outcome Measures:
  1. Adverse Events as Measured by Number of Events Experienced by All Participants [ Time Frame: 30 days after completion of treatment (approximately 22 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Sanofi
Investigators
Layout table for investigator information
Principal Investigator: David G Mutch, M.D. Washington University School of Medicine
Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02469116    
Other Study ID Numbers: 05-1023
First Posted: June 11, 2015    Key Record Dates
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action