NCT Number: NCT00215462
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
About this study
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Secondary outcomes
-
To evaluate the toxicities of vinorelbine in this patient population.
Sponsors and collaborators
Lead sponsor
Dana-Farber Cancer Institute
Other
Collaborators
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
- Massachusetts General Hospital
Registry information
Official study title
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Important dates
- Study start
- 2000
- Primary completion
- 2005
- Study completion
- 2005
- First posted
- Sep 22, 2005
- Registry last updated
- Apr 28, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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