Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

NCT00109850

Esophageal Cancer

TERMINATED PHASE2

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

NCT02569242

Esophageal Cancer

COMPLETED PHASE3

Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach

NCT02358863

Esophageal Cancer Gastric Cancer

TERMINATED NA

Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

NCT04046575

Esophagus Cancer Esophageal Cancer Cancer of the Esophagus

ACTIVE_NOT_RECRUITING PHASE1

Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

NCT00165490

Adenocarcinoma of Esophagus Squamous Cell Carcinoma of Esophagus

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer Gastric Cancer Stomach Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vinorelbine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No