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

NCT ID: NCT02469116

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-03-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Pegylated G-CSF

Intervention Type: DRUG

Interventions

Docetaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Pegylated G-CSF

Intervention Type: DRUG

Other Intervention Names

Docefrez®; Taxotere®; Paraplatin; CBDCA; Neulasta®); Pegfilgrastim

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David G Mutch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

05-1023

Identifier Type: -

Identifier Source: org_study_id