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

• ClinicalTrials.gov Identifier: NCT03858166
• Recruitment Status: Unknown
• First Posted: February 28, 2019
• Last Update Posted: February 28, 2019
• Sponsor: Shandong University
• Information provided by (Responsible Party): Beihua Kong, Shandong University

Tracking Information

• First Submitted Date: February 25, 2019
• First Posted Date: February 28, 2019
• Last Update Posted Date: February 28, 2019
• Actual Study Start Date: December 1, 2017
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 27, 2019)

• 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
• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Adjuvant Chemotherapy
• Ovarian Neoplasms
• Ovarian Cancer

Intervention

Drug: PEG-rhG-CSF

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

Study Arms

• Active Comparator: Standard group
  6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.
  Intervention: Drug: PEG-rhG-CSF
• Experimental: Adjusted group
  6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.
  Intervention: Drug: PEG-rhG-CSF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 27, 2019): 1190
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03858166
• Other Study ID Numbers: WJW-2-PEG-OC
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Beihua Kong, Shandong University
• Study Sponsor: Shandong University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shandong University
• Verification Date: February 2019