Status:
TERMINATED
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
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Gastric Cancer
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 o...
Detailed Description
Background Information: Capecitabine is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine which is converted to 5-fluorouracil. Capecitabine is readily absorbed from the gastrointes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00130936
Start Date
October 1 2005
End Date
November 1 2007
Last Update
February 15 2016
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2