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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130936
First Posted: August 17, 2005
Last Update Posted: February 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AHS Cancer Control Alberta
  Purpose

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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • recommended phase II dose

Secondary Outcome Measures:
  • preliminary study of efficacy

Estimated Enrollment: 50
Study Start Date: October 2005
Study Completion Date: November 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced cancer
  • Gastric or esophageal cancer
  • Adequate organ function and bone marrow reserve
  • In general, patients must be 18 years or older
  • Life expectancy of > 12 weeks
  • World Health Organization (WHO) performance status 0-2
  • Left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) > 50%
  • Adequate organ function: hematological (ANC > 1.5 x 10^9/L; platelets > 100 x 10^9/L); hepatic (bilirubin < 1.5 x upper limit of normal [ULN]; AST/ALT < 3 x ULN); renal (calculated creatinine clearance > 60 ml/min).
  • Negative pregnancy test for females with child-bearing potential
  • Prior radiotherapy allowed but must be delivered to < 25% of bone marrow; must be completed > 4 weeks before study entry; and patients must have recovered from all side effects of the radiotherapy. Radiation must not be delivered to the sole response indicator lesion, unless there is documented evidence of disease progression in that site after completion of radiation.
  • Patients must be able to reliably tolerate and comply with oral/feeding tube administered medications (patients are considered eligible if the investigator deems that there is no malabsorption syndrome and no gastrointestinal [GI] obstruction that would impair the delivery of orally administered chemotherapy).
  • If patient has had prior anthracycline, cumulative dose must be < 300mg/m2 of doxorubicin or its equivalent.

Exclusion Criteria:

  • Abnormal organ function or active infection
  • Patients currently enrolled in another clinical trial involving active cancer treatment.
  • Treatment with doxorubicin > 300mg/m2 or its equivalent.
  • Serious medical conditions including myocardial infarction within 6 months prior to entry; unstable angina; active cardiomyopathy; unstable ventricular arrhythmia; congestive heart failure; uncontrolled hypertension; uncontrolled psychotic disorders; serious active infections; uncontrolled diabetes or any other medical condition that might be aggravated by study treatment.
  • Pre-existing neuropathy > grade 1
  • History of seizures or patients receiving anti-epileptic prophylaxis
  • Active and or progressive brain or leptomeningeal metastasis
  • Pregnant or lactating women
  • Patients with evidence or recent history of drug or alcohol abuse
  • Prior treatment with capecitabine or infusional 5-FU
  • Known hypersensitivity to carboplatin
  • 5-FU, anthracyclines or known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Patients that lack physical integrity of the gastrointestinal (GI) tract leading to intestinal obstruction.
  • Patients taking warfarin (Coumadin) or other coumarin derivatives.
  • Presence of any mentally incapacitating psychological condition.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130936


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Michael Sawyer, MD AHS Cancer Control Alberta
  More Information

ClinicalTrials.gov Identifier: NCT00130936     History of Changes
Other Study ID Numbers: GI-05-0046
First Submitted: August 15, 2005
First Posted: August 17, 2005
Last Update Posted: February 15, 2016
Last Verified: September 2009

Keywords provided by AHS Cancer Control Alberta:
phase I
epirubicin
solid tumors

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Carboplatin
Capecitabine
Epirubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors