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

Primary Purpose

Adjuvant Chemotherapy, Ovarian Neoplasms, Ovarian Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

PEG-rhG-CSF

About this trial

This is an interventional treatment trial for Adjuvant Chemotherapy focused on measuring PEG-rhG-CSF, secondary prophylaxis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18 years or older
Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
Grade 3/4 neutropenia appeared in previous chemotherapy
accept at least 3 cycles of adjuvant chemotherapy
expected survival time ≥ 8 months; KPS>70
Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L
No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction
Liver function: ALT, TBIL, AST <= 2.5 ULN
Renal function: Cr, BUN <= 1.5 ULN
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.
Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.

Exclusion Criteria:

Uncontrolled infection, temperature≥38℃
patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
undergoing any other clinical trial in 4 weeks before recruitment
undergoing radiotherapy in 4 weeks before recruitment
Patients with other malignant tumors who have not been cured or have brain metastasis
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
Severe heart, kidney, liver and other important organs chronic diseases
severe and uncontrolled diabetes
Pregnancy or lactation in women or women of childbearing age refused to accept contraception
People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
Suspected or confirmed drug use, drug abuse, alcoholics
Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
HIV positive
Syphilis infection
The investigator believes that the patient's condition is not suitable for this clinical study.

Sites / Locations

Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard group

Adjusted group

Arm Description

6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.

6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.

Outcomes

Primary Outcome Measures

Incidence of grade 3/4 neutropenia

The duration of grade 3/4 neutropenia

Secondary Outcome Measures

Full Information

NCT ID

NCT03858166

First Posted

February 25, 2019

Last Updated

February 27, 2019

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT03858166

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adjuvant Chemotherapy, Ovarian Neoplasms, Ovarian Cancer

Keywords

PEG-rhG-CSF, secondary prophylaxis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard group

Arm Type

Active Comparator

Arm Description

6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.

Arm Title

Adjusted group

Arm Type

Experimental

Arm Description

6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.

Intervention Type

Drug

Intervention Name(s)

PEG-rhG-CSF

Intervention Description

6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.

Primary Outcome Measure Information:

Title

Incidence of grade 3/4 neutropenia

Description

Incidence of grade 3/4 neutropenia

Time Frame

At the end of cycle 2 (each cycle is 21 days)

Title

The duration of grade 3/4 neutropenia

Description

The duration of grade 3/4 neutropenia

Time Frame

At the end of cycle 2 (each cycle is 21 days)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 years or older Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer Grade 3/4 neutropenia appeared in previous chemotherapy accept at least 3 cycles of adjuvant chemotherapy expected survival time ≥ 8 months; KPS>70 Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction Liver function: ALT, TBIL, AST <= 2.5 ULN Renal function: Cr, BUN <= 1.5 ULN 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. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent. Exclusion Criteria: Uncontrolled infection, temperature≥38℃ patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment undergoing any other clinical trial in 4 weeks before recruitment undergoing radiotherapy in 4 weeks before recruitment Patients with other malignant tumors who have not been cured or have brain metastasis 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 Severe heart, kidney, liver and other important organs chronic diseases severe and uncontrolled diabetes Pregnancy or lactation in women or women of childbearing age refused to accept contraception People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products Suspected or confirmed drug use, drug abuse, alcoholics Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation HIV positive Syphilis infection The investigator believes that the patient's condition is not suitable for this clinical study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beihua Kong, MD, PhD

Phone

+8618560081888

kongbeihua@sdu.edu.cn

Facility Information:

Facility Name

Qilu Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beihua Kong, MD, PhD

Phone

+8653182169562

12. IPD Sharing Statement

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

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