Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03858166
Other study ID # WJW-2-PEG-OC
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2