Clinical trial NCT02469116: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2015-06-11
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3
timeFrame: Through 30 days after completion of treatment (approximately 22 weeks)
Secondary outcomes:
measure: Efficacy of Regimen as Measured by CA-125 Response
timeFrame: Completion of treatment (approximately 18 weeks)
measure: Time to Progression (TTP)
timeFrame: Completion of follow-up
measure: Overall Survival (OS)
timeFrame: Completion of follow-up
measure: Progression-free Survival (PFS)
timeFrame: Completion of follow-up
measure: Quality of Life (QoL) as Measured by FACT-O Assessment Tool
timeFrame: Completion of follow-up
Other outcomes:
measure: Adverse Events as Measured by Number of Events Experienced by All Participants
timeFrame: 30 days after completion of treatment (approximately 22 weeks)
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: David G Mutch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: