Esophageal Cancer, Gastric Cancer, Stomach Cancer
Conditions
Keywords
gastric adenocarcinoma, esophageal adenocarcinoma, vinorelbine
Brief summary
The purpose of this study is to collect anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors. We will also collect information on the toxicities of vinorelbine in these patients.
Detailed description
* Patients will receive vinorelbine intravenously once per week for eight weeks. These treatments will be repeated after the initial eight weeks as long as the patient continues to receive benefit from the treatment. If the patient experiences significant toxicities, the dose may be reduced or the chemotherapy may be discontinued. * Before beginning treatment and during therapy, routine laboratory tests, scans and x-rays will be done to check the body's response to treatment. A physical exam will be done at the start of the study and before each course of treatment. Scans will be done after eight weeks of therapy. * Patients will remain on this study as long as their disease does not become worse or they do not experience severe side effects.
Interventions
DRUGVinorelbine
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally unresectable or metastatic esophageal adenocarcinoma. Locally unresectable or metastatic gastric adenocarcinoma. Only patients with measurable tumors are eligible. * No more than one prior chemotherapy regimen * ECOG performance status of 0-1 * Life expectancy of \> 12 weeks * Greater than or equal to 1,200 calorie/day intake * ANC \> 1,500/mm3 * AST \< 3 x ULN * Total bilirubin \< 2.0 ng/dl * Platelets \> 100,000/mm3 * Serum creatinine \< 2.0 mg/dl
Exclusion criteria
* Prior therapy with vinca alkaloids * Chemotherapy within the past three weeks * Clinically apparent central nervous system metastases or carcinomatous meningitis * Peripheral neuropathy \> 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the toxicities of vinorelbine in this patient population. | — |
Countries
United States
Outcome results
None listed