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

NCT03858166 | Terminated Phase 4 DMC

• 1 other identifier: WJW-2-PEG-OC
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Adjuvant Chemotherapy; Ovarian Neoplasms; Ovarian Cancer

Keywords

PEG-rhG-CSF; secondary prophylaxis

Outcome Measures

Primary Outcomes (2)

• Incidence of grade 3/4 neutropenia

  Incidence of grade 3/4 neutropenia

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

• 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)

Study Arms (2)

Standard group

ACTIVE COMPARATOR

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

Drug: PEG-rhG-CSF

Adjusted group

EXPERIMENTAL

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

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSF DRUG

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

Adjusted group; Standard group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 28, 2019
• Study Start: December 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

CN (1)