Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00215462|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer Stomach Cancer||Drug: Vinorelbine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
- To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
- To evaluate the toxicities of vinorelbine in this patient population.
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): NCT00215462
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Matthew Kulke, MD||Dana-Farber Cancer Institute|