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Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients

Primary Purpose

Gastric Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

nanoparticle Albumin-Bound paclitaxel

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring advanced, paclitaxel, capecitabine, first line therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

signed informed consent form;
histologically or cytologically confirmed gastric cancer;
Age 18-75 years;
Advanced or recurrent, metastatic disease;
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
Life expectancy of at least 12 weeks;
At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors );
no prior history of chemotherapy or beyond 6 months after the end of systemic adjuvant treatment;
Haematopoietic status:
- Absolute neutrophil count > 1.5 x 109/L;
- Platelet count > 90 x 109/L;
- Hemoglobin at least 90g/l;
Hepatic status:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN);
- AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤ 5 times ULN (with liver metastasis);
- ALP ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver or bone metastasis);
- serum albumin ≥ 30g/L;
Renal status:
- Creatinine ≤ 1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥ 40 mL/min;
Able to swallow and retain oral medication;

Exclusion Criteria:

peripheral neuropathy of grade 2 or greater;
symptomatic brain metastasis;
known history of uncontrolled or symptomatic angina;
clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
active or uncontrolled infection;
pregnant or lactating women;
dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine
unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract hemorrhage

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nanoparticle Albumin-bound paclitaxel

Arm Description

evaluate one dose level of nab-paclitaxel:125mg/m2

Outcomes

Primary Outcome Measures

progression free survival

the follow-up visit of PFS will be performed every 6 weeks

Secondary Outcome Measures

objective response rate

CT/MRI/Ultrasound will be performed every 2 cycles of treatment for efficacy evaluation

overall survival of participants

OS means that from the first dose of treatment drug to death or lost,the follow-up visit will be performed every 3 months till death or lost

biomarkers

To identify the molecular biomarkers(such as SPARK,β-Tubulin III,caveolin,etc)by immunohistochemical and western-bloting before and during therapy,to study the biomarkers correlations with clinical outcome and toxicity.

Full Information

NCT ID

NCT01641783

First Posted

July 11, 2012

Last Updated

July 13, 2012

Sponsor

Yanqiao Zhang

1. Study Identification

Unique Protocol Identification Number

NCT01641783

Brief Title

Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients

Official Title

To Evaluate the Efficacy and Safety of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients:a Phase II Single Center Prospective Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yanqiao Zhang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Gastric cancer remains one of the major causes of cancer deaths around the world,especially in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still poor, so the investigators urgently need an effective strategy to treat advanced gastric cancer, however, there was no recommended First-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in breast cancer as first-line chemotherapy in many countries. The investigator then initiated a prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer to observe the efficacy and safety.

Detailed Description

A single arm,open,phase II study of Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer. Nab-Paclitaxel should be given intravenously on days 1 and 8 at a dose as follows. Treatment should be repeated every 3 weeks:Nab-Paclitaxel:125 mg/m2; Capecitabine should be given orally twice a day as follows for 14 consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. Capecitabine:1000mg/m2,twice daily (bid). If applicable,the value of response and prognosis predictive factors are expected to be identified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenocarcinoma

Keywords

advanced, paclitaxel, capecitabine, first line therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nanoparticle Albumin-bound paclitaxel

Arm Type

Experimental

Arm Description

evaluate one dose level of nab-paclitaxel:125mg/m2

Intervention Type

Drug

Intervention Name(s)

nanoparticle Albumin-Bound paclitaxel

Other Intervention Name(s)

ABI-007

Intervention Description

nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv

Primary Outcome Measure Information:

Title

progression free survival

Description

the follow-up visit of PFS will be performed every 6 weeks

Time Frame

1 year

Secondary Outcome Measure Information:

Title

objective response rate

Description

CT/MRI/Ultrasound will be performed every 2 cycles of treatment for efficacy evaluation

Time Frame

6 weeks

Title

overall survival of participants

Description

OS means that from the first dose of treatment drug to death or lost,the follow-up visit will be performed every 3 months till death or lost

Time Frame

2 years

Title

biomarkers

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: signed informed consent form; histologically or cytologically confirmed gastric cancer; Age 18-75 years; Advanced or recurrent, metastatic disease; Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2; Life expectancy of at least 12 weeks; At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ); no prior history of chemotherapy or beyond 6 months after the end of systemic adjuvant treatment; Haematopoietic status: Absolute neutrophil count > 1.5 x 109/L; Platelet count > 90 x 109/L; Hemoglobin at least 90g/l; Hepatic status: Bilirubin ≤ 1.5 x upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤ 5 times ULN (with liver metastasis); ALP ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver or bone metastasis); serum albumin ≥ 30g/L; Renal status: Creatinine ≤ 1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥ 40 mL/min; Able to swallow and retain oral medication; Exclusion Criteria: peripheral neuropathy of grade 2 or greater; symptomatic brain metastasis; known history of uncontrolled or symptomatic angina; clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen; dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF; active or uncontrolled infection; pregnant or lactating women; dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract hemorrhage

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanqiao Zhang, M.D.

Phone

86-0451-86298222

yanqiaozhang@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ming yang, Master

Phone

86-0451-86298281

yangming_0517@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanqiao Zhang, M.D.

Organizational Affiliation

Harbin Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients

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