A phase II study of low dose nab-paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer

A phase II study of low dose nab-paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer - A phase II study of nab-paclitaxel as second-line chemotherapy for gastric cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016196

Enrollment

Registered

2015-01-13

Start date

2015-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable or recurrent gastric cance

Interventions

Low dose nab-Paclitaxel is administered tri-weekly.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed gastric cancer. 2. Patients with measurable lesions within 28 days before registration. 3. Patients resisted first line chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer. 4. Patients with advanced/recurrent gastric cancer which are resistant to first line chemotherapy within 28 days before registration. 5. No influence of prior therapy. 6. PS 0-2 7. Age >=20 8. Expected more than 3 months survival 9. Adequate organ functions (within 14 days before registration) Leu: >=3,000 /mm3, <=12,000 /mm3 Neu: >= 1,500 /mm3 Plt: >= 100,000 /mm3 Hemoglobin: >= 9.0 g/dL ALT: <=ULNx2.5 AST: <=ULNx2.5 T-bil: =<1.5mg/dl Scr: >= 1.5 mg/dl 10. With written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with serious drug allergy 2. Patients with history of receiving paclitaxel treatment 3. Patients with infectious disease and febrile condition (over 38 centigrade) 4. Patiens with any other serious disease. 5. Patients with severe diarrhea 6. Patients with fresh bleeding from intestinal tract. 7. Patients with serious heart disease 8. Presence of active multiple primaries. (Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.) 9. Patients with peripheral neuropathy(=>Grade2) 10. Patients wit psychological illness 11. Pregnant or nursing female 12. Patient with brain metastasis. 13. Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
RR	—

Secondary

Measure	Time frame
OS, DFS, DCR, Safety, Dose-Intensity, Correlation between SPARC expression and efficacy, QOL	—

Countries

Japan

Contacts

Public ContactShigefumi Yoshino

Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology

sigefumi@yamaguchi-u.ac.jp0836-22-2264

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026