NCT00881816

Brief Summary

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric carcinoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

6 months

First QC Date

April 14, 2009

Last Update Submit

April 14, 2009

Conditions

Advanced Gastric Carcinoma

Keywords

Liposomal PaclitaxelCapecitabineMaximum tolerated doseDose limiting toxicity

Outcome Measures

Primary Outcomes (1)

  • maximum tolerated dose

    6 months

Secondary Outcomes (1)

  • dose limiting toxicity

    6 months

Study Arms (1)

Liposomal paclitaxel plus capecitabine

EXPERIMENTAL
Drug: Liposomal paclitaxel plus capecitabine

Interventions

Liposomal paclitaxel plus capecitabineDRUG

All Patients will receive liposomal paclitaxel (with a dose of 60mg/m2,3h,ivgtt,at d1,8,15) and capecitabine (with a dose of 1600mg/m2,bid,po.,at d1-14),each cycle for 4 cycles.

Liposomal paclitaxel plus capecitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 75
  • Histologically or cytologically documented gastric adenocarcinoma and esophagus-gastro adenocarcinoma of metastatic or advanced stages with/without measurable tumor according to RECIST standard
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Patients who are expected to live at least 3 months
  • No prior systemic chemotherapy with advanced stereo- tumor before the recruitment(recidivist/ metastatic without perioperative chemotherapy at least 6m)
  • No Previous anaphylactic reaction to hormone
  • Obtaining informed consent
  • Patients may comply with the study protocol
  • Laboratory tests: Absolute neutrophil count (ANC) ≥2,000/mm³, Platelet count ≥100,000/mm³, Hemoglobin ≥9.0 g/dL, Serum creatinine≤1.5 x the institutional upper limit of normal (ULN), Creatinine clearance≥50ml/min，Total bilirubin≤1.5 x the institutional upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN. In the case of known liver metastasis, ALT and AST（SGOT） ≤1.5 x ULN.

You may not qualify if:

  • Active uncontrolled central nervous system metastasis
  • No adequate organ function or known disease :
  • myocardial infarction
  • active heart disease
  • neuropathy or mental diseases including dementia or epilepsy
  • blind、deaf、dumb or extremity disability
  • known infection
  • active diffuse intravascular coagulation
  • known infection with hepatitis virus
  • Pregnant or nursing,fertile patients would not use effective contraception during study treatment
  • Prior clinically significant gastrointestinal tract disease , that would influence obviously capecitabine to absorb,including the ability to swallow by the attending physician
  • No other active malignancies except that in complete remission with squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or no recrudescence for at least 2 year from the time a response was first documented
  • Having other study medication within 4w
  • Having radiation therapy or operation within 4w
  • Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jin Li, Dr.

    Cancer Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

April 15, 2009

Record last verified: 2009-04