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

Phase 4

Terminated

• Conditions: Ovarian Neoplasms; Adjuvant Chemotherapy; Ovarian Cancer
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT03858166
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard group	PEG-rhG-CSF	6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.
Adjusted group	PEG-rhG-CSF	6mg PEG-rhG-CSF was administrated subcutaneously when ANC \< 1000/mm3 after chemotherapy.

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3/4 neutropenia	At the end of cycle 2 (each cycle is 21 days)	Incidence of grade 3/4 neutropenia
The duration of grade 3/4 neutropenia	At the end of cycle 2 (each cycle is 21 days)	The duration of grade 3/4 neutropenia

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China