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

NCT02469116 | Terminated Phase 2 Results

• 1 other identifier: 05-1023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Through 30 days after completion of treatment (approximately 22 weeks)

Secondary Outcomes (5)

• Efficacy of Regimen as Measured by CA-125 Response

  Completion of treatment (approximately 18 weeks)

• Time to Progression (TTP)

  Completion of follow-up

• Overall Survival (OS)

  Completion of follow-up

• Progression-free Survival (PFS)

  Completion of follow-up

• Quality of Life (QoL) as Measured by FACT-O Assessment Tool

  Completion of follow-up

Other Outcomes (1)

• Adverse Events as Measured by Number of Events Experienced by All Participants

  30 days after completion of treatment (approximately 22 weeks)

Study Arms (1)

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

EXPERIMENTAL

* 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; Drug: Carboplatin; Drug: Pegylated G-CSF

Interventions

Docetaxel DRUG

Also known as: Docefrez®, Taxotere®

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

Carboplatin DRUG

Also known as: Paraplatin, CBDCA

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

Pegylated G-CSF DRUG

Also known as: Neulasta®), Pegfilgrastim

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Sanofi: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Docetaxel; Carboplatin; pegfilgrastim

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: David G. Mutch, M.D.
• Organization: Washington University School of Medicine

mutchd@wustl.edu

314-362-3181

Study Officials

• David G Mutch, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 11, 2015
• Study Start: January 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 19, 2016
• Results First Posted: August 19, 2016

Record last verified: 2016-07

Locations

US (1)