Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer

NCT02229045 | Unknown Phase 2

• 1 other identifier: ABI-FU
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Caner

Keywords

gastric caner; Albumin Bound Paclitaxel; 5-FU/CF; taxanes naive

Outcome Measures

Primary Outcomes (1)

• PFS(Progression-free survival )

  The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death

  80% PFS events,, an expected average of 10 months

Secondary Outcomes (1)

• OS (Overall survival )

  OS follow-up period: 18 months or 80% OS events, whichever occurs first

Other Outcomes (1)

• ORR (Overall tumor response)

  80% PFS events, an expected average of 10 months

Study Arms (1)

Albumin Bound Paclitaxel With 5-FU/CF

EXPERIMENTAL

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.

Drug: Albumin Bound Paclitaxel; Drug: 5-FU

Interventions

Albumin Bound Paclitaxel DRUG

Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.

Also known as: Abraxane

Albumin Bound Paclitaxel With 5-FU/CF

5-FU DRUG

5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.

Albumin Bound Paclitaxel With 5-FU/CF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
• Male or female.
• Age 18 -75.
• 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.

You may not qualify if:

• 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.
• Known hypersensitivity to any of the study drugs

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; Fluorouracil

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ruihua Xu, PhD,MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruihua Xu, PhD,MD

CONTACT

862087343228; xurh@sysucc.org.cn

Dongsheng Zhang, PhD,MD

CONTACT

862087343795; zhangdsh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: August 29, 2014
• Study Start: November 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

CN (1)