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

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Caner
• Intervention / Treatment: Drug: Albumin Bound Paclitaxel; Drug: 5-FU

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Ruihua Xu, Ph D,MD; Phone Number: 862087343228
      • Contact: Dongsheng Zhang, Ph D,MD; Phone Number: 862087343795; Email: zhangdsh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

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.
• Known hypersensitivity to any of the study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Albumin Bound Paclitaxel; Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.; Other Names: Abraxane; Drug: 5-FU; 5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS (Overall survival )	Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.	OS follow-up period: 18 months or 80% OS events, whichever occurs first

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR (Overall tumor response)	Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.	80% PFS events, an expected average of 10 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Ruihua Xu, PhD,MD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 8, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 27, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: gastric caner; Albumin Bound Paclitaxel; 5-FU/CF; taxanes naive
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: ABI-FU