Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer

January 18, 2017 updated by: Wake Forest University Health Sciences

A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
  • Determine the overall and progression-free survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

Secondary

  • Determine the duration of response in patients treated with this regimen.

OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

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 to 120 years (Adult, 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, including any of the following types:

    • Squamous cell carcinoma
    • Adenocarcinoma, including bronchoalveolar cell adenocarcinoma
    • Large cell anaplastic carcinoma, including giant and clear cell carcinomas
  • Histologic or cytologic documentation of recurrence is required

  • Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging

    • The following lesions are not considered measurable or evaluable:

      • Bone disease only
      • Pleural or pericardial effusions
      • Previously irradiated lesions, unless subsequent progression is documented
  • CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • CALGB performance status ≤ 1
  • Life expectancy ≥ 3 months
  • Granulocyte count > 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2 times normal
  • Bilirubin normal
  • SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR
  • Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal
  • Ejection fraction normal by ECHO or MUGA
  • No history of congestive heart failure
  • No psychiatric illness that would preclude study compliance
  • No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to < 3 months
  • No active uncontrolled bacterial, fungal, or viral infection
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy
  • No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior major surgery and recovered from acute effects

  • At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects

    • Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed
  • No prior chemotherapy
  • No concurrent cranial or thoracic radiation therapy
  • No concurrent cytotoxic or hormonal therapy
  • Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient response rate to weekly taxotere and gemcitabine
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate toxicity of weekly Taxotere and Gemcitabine
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Antonius A. Miller, MD, Wake Forest University Health Sciences

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

November 1, 2000

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000462116
  • CCCWFU-62199
  • AVENTIS-CCCWFU-62199
  • AG-CCCWFU-62199
  • CCCWFU-BG99-322

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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