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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278460
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : January 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer
Study Start Date : November 2000
Actual Primary Completion Date : February 2006
Actual Study Completion Date : September 2007

Intervention Details:
  • Drug: docetaxel
    40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days
  • Drug: gemcitabine hydrochloride
    800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.

Primary Outcome Measures :
  1. patient response rate to weekly taxotere and gemcitabine [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Evaluate toxicity of weekly Taxotere and Gemcitabine [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278460

Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Antonius A. Miller, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00278460     History of Changes
Other Study ID Numbers: CDR0000462116
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: July 2012

Keywords provided by Wake Forest University Health Sciences:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators