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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Adenocarcinoma
• Intervention / Treatment: Drug: nanoparticle Albumin-Bound paclitaxel

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

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:

• 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

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: nanoparticle Albumin-bound paclitaxel; evaluate one dose level of nab-paclitaxel:125mg/m2	Drug: nanoparticle Albumin-Bound paclitaxel; nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv; Other Names: ABI-007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	the follow-up visit of PFS will be performed every 6 weeks	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate	CT/MRI/Ultrasound will be performed every 2 cycles of treatment for efficacy evaluation	6 weeks
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	2 years
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.	6 weeks

Collaborators and Investigators

• Sponsor: Yanqiao Zhang
• Investigators: Principal Investigator: Yanqiao Zhang, M.D., Harbin Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 13, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: capecitabine; paclitaxel; advanced; first line therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: YL2012-03