Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

August 6, 2013 updated by: Cancer Research UK

A Randomized Study of MVP 3 Versus 6 Cycles in Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether three courses of combination chemotherapy are more effective than six courses of combination chemotherapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the duration of symptom control, time to disease progression, survival, and quality of life in patients with stage IIIB or IV non-small cell lung cancer treated with 3 versus 6 courses of mitomycin, vinblastine, and cisplatin.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by stage of disease (stage IIIB vs IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cisplatin IV over 4 hours, mitomycin IV, and vinblastine IV on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during course 3. Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during courses 3 and 5. Quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm I and after completion of 4, 5, and 6 courses for those in arm II. Patients may receive radiotherapy beginning after completion of chemotherapy.

PROJECTED ACCRUAL: A total of 310 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 3

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 Kingdom
    • England
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven stage IIIB or IV non-small cell lung cancer that is not eligible for surgery or radical radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod-WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal (unless due to metastatic disease) Renal: Creatinine clearance greater than 60 mL/min EDTA clearance greater than 60 mL/min Other: No serious, uncontrolled, concurrent medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior conventional chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

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: Randomized

Collaborators and Investigators

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

Sponsor

Cancer Research UK

Investigators

  • Study Chair: Ian E. Smith, MD, Royal Marsden NHS Foundation Trust

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

May 1, 1998

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

September 15, 2004

First Posted (Estimate)

September 16, 2004

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICRF-95.240
  • CDR0000067457 (Registry Identifier: PDQ (Physician Data Query))
  • EU-99017

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.

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