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

NCT ID: NCT01641783

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Gastric Adenocarcinoma

Keywords

advanced; paclitaxel; capecitabine; first line therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nanoparticle Albumin-bound paclitaxel

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

Group Type: EXPERIMENTAL

nanoparticle Albumin-Bound paclitaxel

Intervention Type: DRUG

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

Interventions

nanoparticle Albumin-Bound paclitaxel

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

Intervention Type: DRUG

Other Intervention Names

ABI-007

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanqiao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yanqiao Zhang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yanqiao Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Harbin Medical University

Central Contacts

Yanqiao Zhang, M.D.

Role: CONTACT

Phone: 86-0451-86298222

Email: yanqiaozhang@126.com

Ming yang, Master

Role: CONTACT

Phone: 86-0451-86298281

Email: yangming_0517@163.com

Other Identifiers

YL2012-03

Identifier Type: -

Identifier Source: org_study_id