NCT02229045
Unknown
Phase 2
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Sun Yat-sen University1 site in 1 country37 target enrollmentNovember 2010
Overview
- Phase
- Phase 2
- Intervention
- Albumin Bound Paclitaxel
- Conditions
- Gastric Caner
- Sponsor
- Sun Yat-sen University
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- PFS(Progression-free survival )
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.
Investigators
Ruihua Xu
Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
- •Male or female.
- •Previous one line of non-taxane chemotherapy for advanced/metastatic disease.
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
- •ECOG Performance status 0, 1 or 2
- •Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min.
- •Signed informed consent.
Exclusion Criteria
- •No prior chemotherapy for gastric cancer.
- •Received any investigational drug treatment within 30 days of start of study treatment.
- •Patients with active gastrointestinal bleeding.
- •Neurological toxicity ≥ grade 2 NCI-CTCAE.
- •Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •History or clinical evidence of brain metastases.
- •Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- •Pregnancy women.
- •Subjects with reproductive potential not willing to use an effective method of contraception.
- •Patients with known active infection with HIV.
Arms & Interventions
Albumin Bound Paclitaxel With 5-FU/CF
Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Intervention: Albumin Bound Paclitaxel
Albumin Bound Paclitaxel With 5-FU/CF
Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Intervention: 5-FU
Outcomes
Primary Outcomes
PFS(Progression-free survival )
Time Frame: 80% PFS events,, an expected average of 10 months
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death
Secondary Outcomes
- OS (Overall survival )(OS follow-up period: 18 months or 80% OS events, whichever occurs first)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung CancersLung CancerUntreated Stage IV or Recurrent Squamous Cell Lung CancersNCT02525653Memorial Sloan Kettering Cancer Center40
Completed
Phase 2
Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric CancerGastric CancerNCT02229058Sun Yat-sen University73
Unknown
Phase 2
Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st ChemotherapySmall Cell Lung CancerNCT04698941Shanghai Pulmonary Hospital, Shanghai, China40
Not yet recruiting
Phase 2
The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT04769076The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School40
Not yet recruiting
Phase 2
Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC PatientsAdvanced Non-squamous Non-small-cell Lung CancerRecurrent Non-Squamous Non-Small Cell Lung CancerMetastatic Non-squamous Non Small Cell Lung CancerNCT06028633Peking University First Hospital28