Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to progression in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine whether there is a perceived preference for this oral administration in these patients. V. Determine the quality of life of these patients when treated with this drug. VI. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates in patients treated with this drug.

OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • Illinois
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB or IV non-small cell lung cancer Measurable disease At least 1 lesion that is 2.0 cm or more in longest diameter CNS metastases allowed if previously treated and clinically stable for at least 8 weeks prior to study No meningeal carcinomatosis Participation in translational research component of this study is mandatory

PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: No dysphagia or inability to swallow capsules intact No peripheral neuropathy grade 2 or greater No other significant medical condition that would preclude study No active infection within the past 2 weeks No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this disease within the past 5 years Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow No prior radiotherapy to measurable lesion unless documented progression after therapy No concurrent radiotherapy, including palliative radiotherapy Surgery: At least 3 weeks since prior major surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vinorelbine
Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.
Drug: vinorelbine tartrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Up to 5 years
Up to 5 years
Quality of life
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

February 2, 2004

First Posted (Estimate)

February 3, 2004

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N0022
  • NCI-2012-02369 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000068398 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on vinorelbine tartrate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe