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

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ClinicalTrials.gov Identifier: NCT02229045
Recruitment Status : Unknown
Verified August 2014 by Ruihua Xu, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Gastric Caner Drug: Albumin Bound Paclitaxel Drug: 5-FU Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Study Start Date : November 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: 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.




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


Other Outcome Measures:
  1. ORR (Overall tumor response) [ Time Frame: 80% PFS events, an expected average of 10 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229045


Contacts
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Contact: Ruihua Xu, PhD,MD 862087343228 xurh@sysucc.org.cn
Contact: Dongsheng Zhang, PhD,MD 862087343795 zhangdsh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ruihua Xu, Ph D,MD    862087343228      
Contact: Dongsheng Zhang, Ph D,MD    862087343795    zhangdsh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Ruihua Xu, PhD,MD Sun Yat-sen University

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Responsible Party: Ruihua Xu, Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02229045     History of Changes
Other Study ID Numbers: ABI-FU
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Ruihua Xu, Sun Yat-sen University:
gastric caner
Albumin Bound Paclitaxel
5-FU/CF
taxanes naive
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Fluorouracil
Taxane
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs