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

• Sponsor: Shandong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03858166
• Collaborator: (none)
• Enrollment: 1,190
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 47.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adjuvant Chemotherapy; Ovarian Neoplasms; Ovarian Cancer	Drug: PEG-rhG-CSF	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of grade 3/4 neutropenia [At the end of cycle 2 (each cycle is 21 days)]

   Incidence of grade 3/4 neutropenia

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beihua Kong, Clinical Professor, Shandong University
• ClinicalTrials.gov Identifier: NCT03858166
• Other Study ID Numbers: WJW-2-PEG-OC
• First Posted: Feb 28, 2019
• Last Update Posted: Feb 28, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beihua Kong, Clinical Professor, Shandong University: PEG-rhG-CSF; secondary prophylaxis
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Feb 28, 2019