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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03858166
• Other study ID #: WJW-2-PEG-OC
• Status: Terminated
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2024
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade 3/4 neutropenia	Incidence of grade 3/4 neutropenia	At the end of cycle 2 (each cycle is 21 days)
Primary	The duration of grade 3/4 neutropenia	The duration of grade 3/4 neutropenia	At the end of cycle 2 (each cycle is 21 days)