Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Alberta Cancer Board |
---|---|
Information provided by: | Alberta Cancer Board |
ClinicalTrials.gov Identifier: | NCT00130936 |
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.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer Esophageal Cancer Tumors |
Drug: Epirubicin Drug: Carboplatin Drug: Capecitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Combined Phase I/II 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 |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | November 2007 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Sawyer, MD | 780-432-8248 | michsawy@cancerboard.ab.ca |
Canada, Alberta | |
Cross Cancer Institute | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Clinical Research Unit 780-989-8251 clinical_trials_cci@cancerboard.ab.ca | |
Principal Investigator: Michael Sawyer, MD |
Principal Investigator: | Michael Sawyer, MD | Alberta Cancer Board |
Study ID Numbers: | GI-05-0046 |
Study First Received: | August 15, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00130936 |
Health Authority: | Canada: Health Canada |
phase I epirubicin solid tumors |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Stomach cancer Carboplatin Epirubicin |
Digestive System Diseases Stomach Diseases Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |