Docetaxel and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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

Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV 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.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the toxicity of this treatment in these patients. III. Describe the quality of life parameters of patients receiving this combination therapy. IV. Determine the survival rate of these patients.

OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms (Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II: Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18 months.

Study Type

Interventional

Enrollment (Actual)

106

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
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Quain & Ramstad Clinic, P.C.
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health Systems
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinical and Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57709
        • Rapid City Regional Hospital

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 or cytologically confirmed stage IIIB/IV nonsmall cell lung cancer eligible for first line chemotherapy Measurable disease (must be outside radiation port or proof of progressive disease) Metastatic CNS disease allowed if treated and stable for at least 21 days prior to study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: At least 3 months since prior myocardial infarction No uncontrolled congestive heart failure No uncontrolled arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception Peripheral neuropathy less than grade 2 No history of hypersensitivity to products containing polysorbate 80 No other significant medical condition No meningeal carcinomatosis No weight loss of greater than 10% within past 3 months due to disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to pelvis, spine, or long bones and recovered No prior radiotherapy to at least 30% of bone marrow Surgery: Greater than 4 weeks since prior major surgery Other: At least 3 weeks since prior investigational drugs

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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I: docetaxel + gemcitabine

Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.

Quality of life is assessed before treatment and before each course of therapy.

Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Drug: docetaxel
Drug: gemcitabine hydrochloride
Experimental: Arm II: docetaxel + gemcitabine

Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.

Quality of life is assessed before treatment and before each course of therapy.

Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Drug: docetaxel
Drug: gemcitabine hydrochloride
Experimental: Arm III: docetaxel + gemcitabine

Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.

Quality of life is assessed before treatment and before each course of therapy.

Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Drug: docetaxel
Drug: gemcitabine hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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

February 1, 1999

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

June 23, 2004

First Posted (Estimate)

June 24, 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-982452
  • NCI-2012-02294 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000066887 (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.

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