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Ovarian CancerPhase 2NCT02469116

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

A Phase 2 study testing Docetaxel, Carboplatin and Pegylated G-CSF in people with Ovarian Cancer, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Docetaxel, Carboplatin and Pegylated G-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Jan 2006to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 21Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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
Being tested
Docetaxel, Carboplatin, Pegylated G-CSF
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Docefrez®, Taxotere®

  • CarboplatinDrug

    Also called Paraplatin, CBDCA

  • Pegylated G-CSFDrug

    Also called Neulasta®), Pegfilgrastim

Study groups in NCT02469116
Study groupRoleWhat they receive
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
Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Pegylated G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

  1. 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.

    Measured: Completion of treatment (approximately 18 weeks)

  2. 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.

    Measured: Completion of follow-up

  3. Overall Survival (OS)

    Overall Survival is the observed length of life from entry into the study to death or the date of last contact

    Measured: Completion of follow-up

  4. Progression-free Survival (PFS)

    -Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Completion of follow-up

  5. 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

    Measured: Completion of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2015 (estimated)
  2. Study startJan 2006
  3. Primary completionAug 2009
  4. Study completionMar 2010

Why it stopped: Sponsor withdrew financial support

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02469116
Sponsor's protocol ID
05-1023
Status last verified
Jul 2016
First submitted
1 Jun 2015
Last updated
19 Aug 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Carboplatin and Pegylated G-CSF in people with Ovarian Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3 (time frame: Through 30 days after completion of treatment (approximately 22 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.

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