Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer

January 3, 2024 updated by: Beihua Kong, Shandong University

The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies

This study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Eligible patients were randomly allocated in a "1:1" to "Standard group" ( 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were recruited and randomly allocated in a "1:1" to "Standard group" (6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). Eligible patients enrolled in this study need to receive 6 cycles of docetaxel or paclitaxel (including liposome paclitaxel) and carboplatin on day 1, every 3 weeks. All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older
  2. Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
  3. Grade 3/4 neutropenia appeared in previous chemotherapy
  4. accept at least 3 cycles of adjuvant chemotherapy
  5. expected survival time ≥ 8 months; KPS>70
  6. Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L
  7. No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction
  8. Liver function: ALT, TBIL, AST <= 2.5 ULN
  9. Renal function: Cr, BUN <= 1.5 ULN
  10. All patients must agree to take effective contraceptive measures during the study and within 6 months after discontinuing the treatment. Females of childbearing age must be negative in urinary pregnancy test before the treatment.
  11. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.

Exclusion Criteria:

  1. Uncontrolled infection, temperature≥38℃
  2. patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
  3. undergoing any other clinical trial in 4 weeks before recruitment
  4. undergoing radiotherapy in 4 weeks before recruitment
  5. Patients with other malignant tumors who have not been cured or have brain metastasis
  6. Liver function: ALT, TBIL, AST > 2.5 ULN; If due to liver metastasis, ALT, TBIL, AST > 5 ULN; Renal function: Cr>1.5; Obvious abnormalities in electrocardiogram
  7. Severe heart, kidney, liver and other important organs chronic diseases
  8. severe and uncontrolled diabetes
  9. Pregnancy or lactation in women or women of childbearing age refused to accept contraception
  10. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
  11. Suspected or confirmed drug use, drug abuse, alcoholics
  12. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
  13. HIV positive
  14. Syphilis infection
  15. The investigator believes that the patient's condition is not suitable for this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard group
6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.
Drug: PEG-rhG-CSF
6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.
Experimental: Adjusted group
6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.
Drug: PEG-rhG-CSF
6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3/4 neutropenia
Time Frame: At the end of cycle 2 (each cycle is 21 days)
Incidence of grade 3/4 neutropenia
At the end of cycle 2 (each cycle is 21 days)
The duration of grade 3/4 neutropenia
Time Frame: At the end of cycle 2 (each cycle is 21 days)
The duration of grade 3/4 neutropenia
At the end of cycle 2 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJW-2-PEG-OC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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