NCT01641783

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yanqiao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	nanoparticle Albumin-Bound paclitaxel	nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-07-17
• Last updated: 2012-07-17