Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

NCT00568529 | Suspended Phase 2

• 1 other identifier: XELOX-AGC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.

Conditions

Gastric Cancer

Keywords

Advanced gastric cancer; Response rate; Side effects; time to progression; overall survival

Outcome Measures

Primary Outcomes (1)

• Response Rate

  2-6 months

Secondary Outcomes (1)

• time to progression and overall survival

  1 year

Study Arms (1)

Combine Chemotherapy

EXPERIMENTAL

XELOX(Xeloda and oxaliplatin combination)

Drug: Capecitabine and Oxaliplatin

Interventions

Capecitabine and Oxaliplatin DRUG

Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w

Also known as: XELOX(Xeloda and oxaliplatin combination)

Combine Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
• ECOG performance status ≤1
• Measurable diseases according to the RECIST
• Relapse or refractory after the first-line chemotherapy
• Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).

You may not qualify if:

• Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin
• Have used any of drugs in the regimen in first-line chemotherapy
• Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
• The evidence of CNS metastasis
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Received other chemotherapy regimen after metastasis
• Participated in other clinical trials.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Jin Li, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: February 1, 2010
• Last Updated: May 26, 2010

Record last verified: 2009-08

Locations

CN (1)