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Study of Epirubicin (Pharmorubicin®), Carboplatin (Paraplatin®) and Capecitabine (Xeloda®) (ECC) in the Treatment of Unresectable Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer With Pharmacogenetic Correlates

NCT00130936 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-02-15

No results posted yet for this study

Summary

Although declining in incidence, gastric/gastroesophageal cancer is still a commonly diagnosed malignancy in Canada. Patients who have undergone surgical resection for early disease have a high rate of local recurrence and distant spread. More than 50% of patients present with either locally advanced or metastatic disease. Patients with advanced disease have an extremely poor prognosis, with average survival times ranging from 3 - 9 months. Development of new therapeutic approaches for locally advanced or metastatic gastric/gastroesophageal cancer, is clearly needed.

Despite its proven efficacy, ECF (epirubicin, cisplatin, and infusional 5-fluorouracil \[5-FU\]) has not been widely adopted in North America and is likely due to the technical difficulties and inconvenience associated with infusional chemotherapy. This study will substitute the oral chemotherapy drug capecitabine for infusional 5-FU in addition to substituting intravenous cisplatin with carboplatin (ECC - epirubicin, carboplatin and capecitabine). It is hoped that these substitutions will not only reduce the typical ECF related adverse effects but also allow for a more convenient administration of outpatient chemotherapy. It is also hoped that the genetic correlates of this study may also identify specific populations that preferentially benefit from ECC treatment.

Conditions

Interventions

DRUG

Epirubicin

DRUG

Carboplatin

DRUG

Capecitabine

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Michael Sawyer, MD · AHS Cancer Control Alberta

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Completion
2007-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130936 on ClinicalTrials.gov