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A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer, Stomach Cancer

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Trial Information

A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.

Principal Investigator

Matthew Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

00-012

NCT ID:

NCT00215462

Start Date:

June 2000

Completion Date:

August 2005

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • Stomach Cancer
  • gastric adenocarcinoma
  • esophageal adenocarcinoma
  • vinorelbine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617