Phase II study of nab-paclitaxel as second-line chemotherapy prior fluoropyrimidine resistance for metastatic or recurrent gastric cancer considering dose reduction on early points

Phase II study of nab-paclitaxel as second-line chemotherapy prior fluoropyrimidine resistance for metastatic or recurrent gastric cancer considering dose reduction on early points - Phase II study of nab-paclitaxel as second-line chemotherapy for metastatic or recurrent gastric cancer considering dose reduction on early points (CCOG1303)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012247

Enrollment

Registered

2013-12-01

Start date

2013-12-01

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

gastric cancer

Interventions

nab-paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically proven gastric adenocarcinoma (2) Presence of resected primary tumor to evaluate the expression of SPARC (3) Prior chemotherapy consisted of fluoropyrimidine for unresectable or recurrent gastric cancer (4) No past history of treatment related paclitaxel (5) Age : 20 years old and more (6) Performance status (ECOG) 0-2 (7) Life expectancy : 12 weeks and more (8) Adequate organ functions (9) Ability to understand and willingness to sign a written informed consent before study entry

Exclusion criteria

Exclusion criteria: (1) Past history of severe hypersensitivity to drug (2) Severe infectious disease that requires systemic treatment (3) Second primary malignancy except in situ carcinoma or prior malignancy treated within 5 years (4) Serious illness (5) Congestive heart failure, unstable angina or myocardial infarction (6) Much amount of pleural effusion, ascites or cardiac effusion (7) Peripheral nerve disorder (8) Presence of symptomatic or progressing CNS metastasis (9) Psychological illness (10) Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method. Sexually active fertile men not using effective birth control. (11) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
disease free survival	—

Countries

Japan

Contacts

Public ContactDaisuke Kobayashi

Nagoya University, Graduate School of Medicine Gastroenterorogical Surgery

kobadai@med.nagoya-u.ac.jp052-744-2253

Outcome results

None listed

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